Customed, Inc
Medical device manufacturer in Ramat Gan, IL.
37510(k) clearances
0PMA approvals
699recalls
Device types
- KKX Drape, Surgical, Antimicrobial 11
- LRO General Surgery Tray 6
- HHD Pad, Menstrual, Unscented 3
- FCM Tray, Catheterization, Sterile Urethral… 2
- LRS I.V. Start Kit 2
- LLZ System, Image Processing, Radiological 1
- FYA Gown, Surgical 1
- KNX Collector, Urine, (And Accessories) For… 1
- GJE Tray, Blood Collection 1
- FRG Wrap, Sterilization 1
- CBT Arterial Blood Sampling Kit 1
- JOH Tube Tracheostomy And Tube Cuff 1
- MCY Wound Dressing Kit 1
- MCZ Suture Removal Kit 1
- KYZ Syringe, Irrigating (Non Dental) 1
- LRD Applicator, Ent Drug 1
- HFC Aspirator, Endocervical 1
- FAJ Cystoscope And Accessories, Flexible/Rigid 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260116 | CustoMED ViewerLLZ · Traditional | 06/03/2026SE |
| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | 01/05/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | 12/04/1997SE |
| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | 10/04/1996SE |
| K962596 | Customed Blood Extraction KitGJE · Traditional | 09/27/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | 08/27/1993SEKD |
| K925017 | IV Prep Kit (Non-Sterile)LRS · Traditional | 08/27/1993SE |
| K930986 | Blood Gas Kit (Non-Sterile) Reorder No. 0560CBT · Traditional | 07/14/1993SEKD |
| K925020 | Tracheostomy Care Kit (Sterile)JOH · Traditional | 07/07/1993SESK |
| K925021 | TPN Tray (Sterile)MCY · Traditional | 06/07/1993SEKD |
| K925015 | Sterile Suture Removal KitMCZ · Traditional | 06/07/1993SESK |
| K924809 | Irrigation Tray W/ Bulb SyringeKYZ · Traditional | 06/07/1993SEKD |
| K925022 | Surgical Tray (Sterile)LRD · Traditional | 04/26/1993SE |
| K925016 | Prep Shave Kit (Non-Sterile)LRO · Traditional | 04/26/1993SE |
| K904694 | Customed Angiodrape Pack FemoralKKX · Traditional | 01/02/1991SESK |
| K904693 | Customed Cardiovascular PackKKX · Traditional | 01/02/1991SESK |
| K902191 | Customed Lap Pack IIKKX · Traditional | 10/31/1990SE |
| K901705 | Customed Cysto Pack IIKKX · Traditional | 10/31/1990SE |
| K902032 | O. B. Pack IVHFC · Traditional | 09/28/1990SE |
| K902274 | Customed Cysto Pack IFAJ · Traditional | 09/20/1990SESK |
| K902886 | Customed Basic Pack IIIKKX · Traditional | 09/19/1990SE |
| K902885 | Customed Basic Pack IIKKX · Traditional | 09/19/1990SE |
| K902884 | Customed Basic Pack IKKX · Traditional | 09/19/1990SE |
| K902888 | Customed Orthopedic IILRO · Traditional | 09/10/1990SE |
| K902887 | Customed Arthroscopy PackLRO · Traditional | 09/10/1990SE |
| K903336 | Customed Hip PactLRO · Traditional | 08/29/1990SE |
| K902273 | O. B. Pack IIIHHD · Traditional | 08/21/1990SE |
| K902272 | O. B. Pack IIHHD · Traditional | 08/15/1990SE |
| K902271 | O. B. Pack IHHD · Traditional | 08/15/1990SE |
| K902031 | Customed Lap Pack IVKKX · Traditional | 07/12/1990SE |
| K902030 | Customed Lap Pack IIIKKX · Traditional | 07/12/1990SE |
| K902029 | Customed Lap Pack IKKX · Traditional | 07/12/1990SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-1496-2016 Class II | Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1495-2016 Class II | Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1494-2016 Class II | Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1493-2016 Class II | Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1492-2016 Class II | Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1491-2016 Class II | Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1490-2016 Class II | Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1489-2016 Class II | Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1488-2016 Class II | Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1487-2016 Class II | Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1486-2016 Class II | Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1485-2016 Class II | Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1484-2016 Class II | Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1483-2016 Class II | Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1482-2016 Class II | Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1481-2016 Class II | Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1480-2016 Class II | Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1479-2016 Class II | Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1478-2016 Class II | Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1477-2016 Class II | Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1476-2016 Class II | Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1475-2016 Class II | Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1474-2016 Class II | Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1473-2016 Class II | Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1472-2016 Class II | Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1471-2016 Class II | Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1470-2016 Class II | Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1469-2016 Class II | Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1468-2016 Class II | Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1467-2016 Class II | Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1466-2016 Class II | Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1465-2016 Class II | Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1464-2016 Class II | Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1463-2016 Class II | Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1462-2016 Class II | Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1461-2016 Class II | Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1460-2016 Class II | Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1459-2016 Class II | Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1458-2016 Class II | Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1457-2016 Class II | Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1456-2016 Class II | Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1455-2016 Class II | Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1454-2016 Class II | Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1453-2016 Class II | Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1452-2016 Class II | Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1451-2016 Class II | Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1450-2016 Class II | Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1449-2016 Class II | Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1448-2016 Class II | Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1447-2016 Class II | Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1446-2016 Class II | Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1445-2016 Class II | Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1444-2016 Class II | Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1443-2016 Class II | Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1442-2016 Class II | Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1441-2016 Class II | Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1440-2016 Class II | Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1439-2016 Class II | Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1438-2016 Class II | Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1437-2016 Class II | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1436-2016 Class II | Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1435-2016 Class II | Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1434-2016 Class II | Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1433-2016 Class II | Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1432-2016 Class II | Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1431-2016 Class II | Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1430-2016 Class II | Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1429-2016 Class II | Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1428-2016 Class II | Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1427-2016 Class II | Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1426-2016 Class II | Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1425-2016 Class II | Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1424-2016 Class II | Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1423-2016 Class II | Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1422-2016 Class II | Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1421-2016 Class II | Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1420-2016 Class II | Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1419-2016 Class II | Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1418-2016 Class II | Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1417-2016 Class II | Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1416-2016 Class II | Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1415-2016 Class II | Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1414-2016 Class II | Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1413-2016 Class II | Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1412-2016 Class II | Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1411-2016 Class II | Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1410-2016 Class II | Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1409-2016 Class II | Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1408-2016 Class II | Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1407-2016 Class II | Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1406-2016 Class II | Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1405-2016 Class II | Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1404-2016 Class II | Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1403-2016 Class II | Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1402-2016 Class II | Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1401-2016 Class II | Catalog Number: 900028 LAPAROSCOPY SURGICAL PACKRecall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1400-2016 Class II | Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1399-2016 Class II | Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1398-2016 Class II | Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-1397-2016 Class II | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 01/07/2016Terminated |
| Z-2717-2015 Class II | C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2716-2015 Class II | PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2715-2015 Class II | LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2714-2015 Class II | ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2713-2015 Class II | CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2712-2015 Class II | C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2711-2015 Class II | PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2710-2015 Class II | CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2709-2015 Class II | ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2708-2015 Class II | UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2707-2015 Class II | CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2706-2015 Class II | LAPAROTOMY PACK CS/6 Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2705-2015 Class II | FEMORAL ANGIOGRAPHY PACK 4/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2704-2015 Class II | GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2703-2015 Class II | SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2702-2015 Class II | INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2701-2015 Class II | CARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2700-2015 Class II | ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2699-2015 Class II | ARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2698-2015 Class II | CESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2697-2015 Class II | O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2696-2015 Class II | PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2695-2015 Class II | FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2694-2015 Class II | O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2693-2015 Class II | ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2692-2015 Class II | LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2691-2015 Class II | ANGIOGRAPHY PACK 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2690-2015 Class II | LAPAROSCOPY GYN PK CS/4 Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2689-2015 Class II | UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2688-2015 Class II | LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2687-2015 Class II | PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2686-2015 Class II | LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2685-2015 Class II | GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2684-2015 Class II | SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2683-2015 Class II | GOWN POLYREINF XLGE TOWEL/W 24/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2682-2015 Class II | LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2681-2015 Class II | LAPAROSCOPY OB 6/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2680-2015 Class II | LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2679-2015 Class II | MINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2678-2015 Class II | CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2677-2015 Class II | LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2676-2015 Class II | GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2675-2015 Class II | LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2674-2015 Class II | CESAREAN PACK 2/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2673-2015 Class II | MAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2672-2015 Class II | CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2671-2015 Class II | ANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2670-2015 Class II | BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2669-2015 Class II | BREAST PACK-TPSC 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2668-2015 Class II | GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2667-2015 Class II | LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2666-2015 Class II | FACE PACK FJG 8/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2665-2015 Class II | TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2664-2015 Class II | FACE LIFT 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2663-2015 Class II | BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2662-2015 Class II | HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2661-2015 Class II | OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2660-2015 Class II | CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2659-2015 Class II | ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2658-2015 Class II | BASIC PACK 8/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2657-2015 Class II | LAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2656-2015 Class II | URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2655-2015 Class II | SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2654-2015 Class II | SHOULDER PACK 3/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2653-2015 Class II | REEMPLAZO DE RODILLA Y CADERA 2/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2652-2015 Class II | SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2651-2015 Class II | TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2650-2015 Class II | FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2649-2015 Class II | OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2648-2015 Class II | SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2647-2015 Class II | EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2646-2015 Class II | HIP AND KNEE REPLACEMENT 3/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2645-2015 Class II | ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2644-2015 Class II | GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2643-2015 Class II | GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2642-2015 Class II | GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2641-2015 Class II | O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2640-2015 Class II | LAPAROTOMY PACK 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2639-2015 Class II | SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2638-2015 Class II | MINOR PACK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2637-2015 Class II | UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2636-2015 Class II | EENT PACK I (1) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2635-2015 Class II | (1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2634-2015 Class II | EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2633-2015 Class II | EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2632-2015 Class II | LUMBAR PACK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2631-2015 Class II | CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2630-2015 Class II | LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2629-2015 Class II | NEURO PACK 2/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2628-2015 Class II | EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2627-2015 Class II | SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2626-2015 Class II | SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2625-2015 Class II | LITHOTOMY PACK 10/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2624-2015 Class II | FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2623-2015 Class II | KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2622-2015 Class II | ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2621-2015 Class II | GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2620-2015 Class II | GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2619-2015 Class II | GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |
| Z-2618-2015 Class II | ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | 07/10/2015Terminated |