Class IIDeviceOngoing

Medline Industries, LP

Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B

Reason for recall

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Details

Recall number: Z-3058-2026
Event ID: 99334
Recall initiated: Jun 12, 2026
Classified: Aug 31, 2026
Reported: Sep 9, 2026
Quantity: 13032 kits
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Northfield, IL, United States
Lot / code info: 1) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case), Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case), Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case), Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case), Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case), Lot Number: 25EBD220