Recall Z-1079-2023
MEDLINE INDUSTRIES, LP - Northfield · initiated November 17, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA
Codes / lots: a. BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/GTIN: 10889942614134, Lot Number: 22IBR514; b. LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/GTIN: 10888277749375, Lot Number: 22JMG555; c. MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/GTIN: 10888277906457, Lot Number: 22JMG570,22JMC877; d. UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/GTIN: 10195327050955, Lot Number: 22HBU946; e. UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/GTIN: 10195327251192, Lot Number: 22JBV588; f. SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/GTIN: 10195327231606, Lot Number: 22JMF540; g. ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/GTIN: 10888277793835, Lot Number: 22JBO588,22IBV960; h. GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/GTIN: 10193489540666, Lot Number: 22IMG415; i. BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/GTIN: 10193489540376, Lot Number: 22JMG578; j. MINOR, Item Number:…
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA-determined cause: Device Design
Action taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Details
- Recall number
- Z-1079-2023
- Initiated
- November 17, 2022
- Posted by FDA
- February 6, 2023
- Product code
- LRO – General Surgery Tray
- Quantity
- 62,930 cases (215,456 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1060-2023 Class II | ANCILLARY PACK-LF. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1061-2023 Class II | TRACH PACK. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1062-2023 Class II | LOCAL PACK. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1063-2023 Class II | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASICSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1064-2023 Class II | UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural TraySterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1065-2023 Class II | FEMORAL ARTERY PACK-LF. Sterile Procedural TraySterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1066-2023 Class II | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1067-2023 Class II | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1068-2023 Class II | Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1069-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1070-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1071-2023 Class II | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1072-2023 Class II | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1073-2023 Class II | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1074-2023 Class II | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1075-2023 Class II | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1076-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDOSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1077-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1078-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1080-2023 Class II | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1081-2023 Class II | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1082-2023 Class II | Sterile Procedural Trays, labeled as the following: IM NAILSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1083-2023 Class II | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1084-2023 Class II | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LFSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1085-2023 Class II | Sterile Procedural Trays, labeled as the following: LS MS PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1086-2023 Class II | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1087-2023 Class II | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1088-2023 Class II | Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1089-2023 Class II | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1090-2023 Class II | Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |