American Contract Systems, Inc.
Medical device manufacturer in Tiffin, OH.
0510(k) clearances
0PMA approvals
210recalls
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-3003-2026 Class II | American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HThe Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | 06/29/2026Open, Classified |
| Z-3002-2026 Class II | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | 06/29/2026Open, Classified |
| Z-3001-2026 Class II | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | 06/29/2026Open, Classified |
| Z-3000-2026 Class II | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | 06/29/2026Open, Classified |
| Z-2990-2026 Class II | American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | 05/19/2026Open, Classified |
| Z-2989-2026 Class II | American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK -…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | 05/19/2026Open, Classified |
| Z-1981-2026 Class I | Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating…Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during… | 03/19/2026Open, Classified |
| Z-0187-2026 Class II | Medical convenience kits IHDC30R D AND C PACKIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0186-2026 Class II | Medical convenience kits UDPG88W PICC G-TUBE PACK-230209Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0185-2026 Class II | Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0184-2026 Class II | Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0183-2026 Class II | Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0182-2026 Class II | Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0181-2026 Class II | Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0180-2026 Class II | Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0179-2026 Class II | Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0178-2026 Class II | Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0177-2026 Class II | Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0176-2026 Class II | Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0175-2026 Class II | Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0174-2026 Class II | Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0173-2026 Class II | Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK -…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0172-2026 Class II | Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0171-2026 Class II | Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL…Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-0170-2026 Class II | Basic Biopsy Tray, Item Number NMBP44LIdentified products were re-gassed (sterilized more than once) after a nonconformance occurred during the… | 09/04/2025Open, Classified |
| Z-2472-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2471-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2470-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2469-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2468-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2467-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2466-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2465-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-2464-2025 Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK -…During an internal investigation, ACS determined that the rationale for sterilization of certain components… | 07/14/2025Open, Classified |
| Z-1916-2025 Class II | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK…Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene… | 04/21/2025Open, Classified |
| Z-1362-2025 Class II | VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1361-2025 Class II | THORACIC PACK , Model No UTTC82Y UTTC82AA-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1360-2025 Class II | SPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1359-2025 Class II | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1358-2025 Class II | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1357-2025 Class II | GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1356-2025 Class II | AV FISTULA , Model No UTAV77TACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1355-2025 Class II | NEURO IR TRAY , Model No WENI56JACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1354-2025 Class II | DIAGNOSTIC NEURO IR TRAY , Model No WENE21ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1353-2025 Class II | CV BASIC PUMP PACK , Model No WECV23DACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1352-2025 Class II | LAPAROSCOPY PACK , Model No SFLA02A SFLA02BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1351-2025 Class II | EAR PACK , Model No SFEA12AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1350-2025 Class II | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1349-2025 Class II | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1348-2025 Class II | DELIVERY PACK , Model No SGDV22D-01 SGDV22EACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1347-2025 Class II | TOTAL HIP PACK , Model No SMTH06O SMTH06PACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1346-2025 Class II | CYSTO , Model No SACY80RACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1345-2025 Class II | URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1344-2025 Class II | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1343-2025 Class II | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1342-2025 Class II | C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1341-2025 Class II | BORN ON ARRIVAL KIT , Model No LLBN11BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1340-2025 Class II | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1339-2025 Class II | OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1338-2025 Class II | LABOR & DELIVERY PACK, Model Nos LLLD19HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1337-2025 Class II | LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1336-2025 Class II | C-SECTION PACK, Model Nos LLCS44F LLCS44F-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1335-2025 Class II | CYSTO PACK , Model N. HKCY31AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1334-2025 Class II | MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1333-2025 Class II | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1332-2025 Class II | DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1331-2025 Class II | LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1406-2025 Class II | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required… | 02/04/2025Open, Classified |
| Z-1426-2025 Class II | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278…Sterility assurance with procedure trays | 01/31/2025Open, Classified |
| Z-1425-2025 Class II | Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number:…Sterility assurance with procedure trays | 01/31/2025Open, Classified |
| Z-1424-2025 Class II | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E…Sterility assurance with procedure trays | 01/31/2025Open, Classified |
| Z-3244-2024 Class II | Pacemaker, COPM11B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3243-2024 Class II | Cysto, FTCY03L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3242-2024 Class II | Nasal Sinus Pack, MTSN26B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3241-2024 Class II | ENT, COEN27N; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3240-2024 Class II | Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3239-2024 Class II | Cath Lab Pack, CECL02P; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3238-2024 Class II | Vaginal Delivery, ASDV25B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3237-2024 Class II | Hand Pack, AKHD97C; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3236-2024 Class II | Neuro Vascular, ANKV91A; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3235-2024 Class II | IR Procedure Pack, CEAT19W; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3234-2024 Class II | Paracentesis Thoracente, SLPT76H; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3233-2024 Class II | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3232-2024 Class II | Shoulder, SESH18I; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3231-2024 Class II | Day Surgery General Pack, FHGE18T; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3230-2024 Class II | Open Shoulder, LWOS39L; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3229-2024 Class II | Arthroscopy Pack, MSKA45A; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3228-2024 Class II | Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3227-2024 Class II | Endovascular AAA Pack, ESED52B; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-3226-2024 Class II | PACEMAKER PACK, SLCV01J; Medical convenience kitACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one… | 08/07/2024Open, Classified |
| Z-2312-2024 Class II | KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2311-2024 Class II | HAND PACK-Procedure Kit Catalog Number: WEHD16CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2310-2024 Class II | HAND PACK-Procedure Kit Catalog Number: WEHD16BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2309-2024 Class II | ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44SEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2308-2024 Class II | CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2307-2024 Class II | CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AEEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2306-2024 Class II | ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2305-2024 Class II | TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21EEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2304-2024 Class II | ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22VEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2303-2024 Class II | ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22UEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2302-2024 Class II | TOTAL KNEE-Procedure Kit Catalog Number: SMTK21CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2301-2024 Class II | KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14GEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2300-2024 Class II | HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67FEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2299-2024 Class II | TOTAL KNEE-Procedure Kit Catalog Number: SFTK54BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2298-2024 Class II | KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2297-2024 Class II | TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2296-2024 Class II | TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2295-2024 Class II | HAND PACK 297829--Procedure Kit Catalog Number: RGHN04IEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2294-2024 Class II | TOTAL KNEE -Procedure Kit Catalog Number: QPTK95BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2293-2024 Class II | TOTAL KNEE -Procedure Kit Catalog Number: QPTK95AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2292-2024 Class II | KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2291-2024 Class II | KNEE ARTHROSCOPY PACK Catalog Number: MEKA12REthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2290-2024 Class II | TOTAL KNEE, ST LUKES Catalog Number: LMTK17APEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2289-2024 Class II | ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2288-2024 Class II | UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2287-2024 Class II | KNEE SCOPE Procedure tray Catalog Number: COKN48LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2286-2024 Class II | HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2285-2024 Class II | FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2284-2024 Class II | BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2283-2024 Class II | ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2282-2024 Class II | ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2281-2024 Class II | ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2280-2024 Class II | ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2279-2024 Class II | TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01ZEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2278-2024 Class II | TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2277-2024 Class II | LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56XEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2276-2024 Class II | MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2275-2024 Class II | TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AFEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2274-2024 Class II | AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual… | 05/15/2024Open, Classified |
| Z-2524-2024 Class II | American Contract Systems Spine Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2523-2024 Class II | American Contract Systems Biopsy Drape Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2522-2024 Class II | American Contract Systems Cataract Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2521-2024 Class II | American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack…Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2520-2024 Class II | American Contract Systems Special Procedure Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2519-2024 Class II | American Contract Systems Laparoscopy Litho Std Pack convenience kit and American…Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2518-2024 Class II | American Contract Systems Gyn Laparoscopy convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-2517-2024 Class II | American Contract Systems Hand Pack convenience kitProduct released with insufficient aeration time impacting the kits sterilized on the same cycle or in the… | 05/06/2024Open, Classified |
| Z-0833-2024 Class II | Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0832-2024 Class II | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0831-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0830-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0829-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0828-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0827-2024 Class II | Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0826-2024 Class II | Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0825-2024 Class II | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a)…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0824-2024 Class II | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a)…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0823-2024 Class II | Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0822-2024 Class II | Custom procedural convenience kits and trays, gastroenterological & urological, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0821-2024 Class II | Custom procedural convenience kits and trays, gastroenterological & urological, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0820-2024 Class II | Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0819-2024 Class II | Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0818-2024 Class II | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0817-2024 Class II | Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0816-2024 Class II | Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0182-2024 Class II | Cath Cardiac Pack, REF IHCC03VDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0181-2024 Class II | Pediatric Urology Wolson Pack, REF BPPU55ADuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0180-2024 Class II | Sub Q Recorder Pack, REF BPRC87ADuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0179-2024 Class II | Robotics Pack, REF SSRO22DDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0178-2024 Class II | Robotics Pack, REF SJVO56BDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0177-2024 Class II | Vasc. Open CVOR SJH, REF SJVO56BDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0176-2024 Class II | Pediatric Heart SJH, REF SJPH34KDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0175-2024 Class II | CVS PCSU SJH, REF SJCV48JDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0174-2024 Class II | Robotics Pack SAH, REF SAR530MDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0173-2024 Class II | Breast Plastics Pack, REF BBPL20DDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0172-2024 Class II | LAVH, REF BBLV21CDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-0171-2024 Class II | General Pack, REF BBGP31CDuring an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and… | 09/01/2023Open, Classified |
| Z-1973-2023 Class III | Total Knee Pack, REF CETJ130, medical convenience kitsIncorrect expiration date on product. | 04/17/2023Open, Classified |
| Z-0274-2023 Class II | BASIN SET, MEBS42K, general surgical kitBasin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of… | 10/12/2022Terminated |
| Z-0071-2023 Class II | COVID Test Kit NonsterileKit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. | 08/12/2022Open, Classified |
| Z-1705-2022 Class II | Various eye packs, cataract packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1704-2022 Class II | D&C packProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1703-2022 Class II | Various C-section packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1702-2022 Class II | Various hysterectomy, vaginal packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1701-2022 Class II | Various ob/gyn packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1700-2022 Class II | Various neurology packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1699-2022 Class II | Various convenience packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1698-2022 Class II | Various convenience packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1697-2022 Class II | Breast Abdominoplasty PackProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1696-2022 Class II | Various Port Insertion PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1695-2022 Class II | Various Cysto PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1694-2022 Class II | Various Laparoscopy PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1693-2022 Class II | Various ENT PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1692-2022 Class II | Various PICC Line, Central Line PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1691-2022 Class II | Various Pacemaker Packs, Cardio Thoracic PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1690-2022 Class II | Various Angiography/Cath Lab packs/traysProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1689-2022 Class II | Various Angiography packs/traysProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1277-2022 Class I | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT…Affected products were assembled off-site by individuals who may not have been properly trained. | 05/02/2022Open, Classified |
| Z-1276-2022 Class I | Clean Catch Urine Kit NS 178489, AHMU58AAffected products were assembled off-site by individuals who may not have been properly trained. | 05/02/2022Open, Classified |
| Z-1040-2022 Class II | ACS Cath Lab PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1039-2022 Class II | ACS Lap Chole PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1038-2022 Class II | ACS IR - Angio PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1037-2022 Class II | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand PackProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-1036-2022 Class II | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up TrayProduct was sterilized with a higher than specification EO concentration. | 03/22/2022Open, Classified |
| Z-2179-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2178-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2177-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2176-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2175-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |
| Z-2174-2020 Class II | Sterile Custom Packs to be used in surgical procedures.The surgical gowns were manufactured in a facility that is not registered by the FDA. | 04/13/2020Terminated |