MEDLINE INDUSTRIES, LP - Northfield: Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3

Hazard

There is a potential for the sterility of the device to be compromised.

Details from the source

Reason for recall: There is a potential for the sterility of the device to be compromised. Distribution: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore Quantity: 1894488 units Lot/code info: 1) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324070002; 2) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324110002; 3) MJ18004V2, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324120004; 4) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324090005; 5) MJ18005V2, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324120004; 6) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324070002; 7) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324090003; 8) MJ76126V2, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324110002; 9) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319100003; 10) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110002; 11) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10319110004; 12) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320010001; 13) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320040001; 14) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320060002; 15) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320100001; 16) WAL1901, UDI-DI: 00681131286299(each), 20681131286293(case), Lot Number: 10320110002; 17) WAL1901, UDI-DI: 00681131286299(each), 2068113128

UPC codes

00708820656963, 20708820656967, 10324070002, 10324110002, 10324120004, 00708820656970, 20708820656974, 10324090005, 00708820502734, 40708820502732, 10324090003, 00681131286299, 20681131286293, 10319100003, 10319110002, 10319110004, 10320010001, 10320040001, 10320060002, 10320100001, 10320110002, 10320120003, 10321010002, 10321010005, 10321020003, 10321030004, 10321040003, 10321040005, 10321040007, 10321050006, 10321090002, 10321100002, 10321110004, 10321110005, 10321110007, 10321120006, 10322010004, 10322030003, 10322030004, 10322040004

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.