MEDLINE INDUSTRIES, LP - Northfield: Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 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: 364842 units Lot/code info: 1) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10315040001; 2) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317020005; 3) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317030004; 4) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317120001; 5) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318050003; 6) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318070002; 7) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318080003; 8) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319010004; 9) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319050004; 10) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319060001; 11) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110002; 12) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110004; 13) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320030005; 14) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320050002; 15) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080001; 16) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080002; 17) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot

UPC codes

00888277307400, 40888277307408, 10315040001, 10317020005, 10317030004, 10317120001, 10318050003, 10318070002, 10318080003, 10319010004, 10319050004, 10319060001, 10319110002, 10319110004, 10320030005, 10320050002, 10320080001, 10320080002, 10320100001, 10320100002, 10321030001, 10321040007, 10321050003, 10321050004, 10321090002, 10321110002, 10322070004, 10322080003, 10323030001, 10323030003, 10323070001, 10323080006, 10323090005, 10324010006, 10324040002, 10324070001, 10324090004, 00708820656963, 20708820656967, 10319020001

Source

Official record: FDA (Device enforcement) ↗

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