There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands. Quantity: 4094 units Lot/code info: 1) DYNJ43914B, UDI-DI: 10889942437078(each), 40889942437079(case), Lot Number: 24IBH633; 2) DYNJ65109, UDI-DI: 10193489243826(each), 40193489243827(case), Lot Number: 24IBH739; 3) DYNJ34160D, UDI-DI: 10889942213542(each), 40889942213543(case), Lot Number: 24IBH802; 4) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24IBL195; 5) DYNJ66056, UDI-DI: 10193489318128(each), 40193489318129(case), Lot Number: 24IBR304; 6) DYNJ66212A, UDI-DI: 10195327345075(each), 40195327345076(case), Lot Number: 24JBL025; 7) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBM075; 8) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM318; 9) DYNJ52658D, UDI-DI: 10195327468828(each), 40195327468829(case), Lot Number: 24JBM914; 10) DYNJ37316D, UDI-DI: 10193489672763(each), 40193489672764(case), Lot Number: 24JBT528; 11) DYNJ57440D, UDI-DI: 10193489238655(each), 40193489238656(case), Lot Number: 24JBT877; 12) DYNJ84991, UDI-DI: 10195327444075(each), 40195327444076(case), Lot Number: 24JBV138; 13) DYNJ37231B, UDI-DI: 10884389871652(each), 40884389871653(case), Lot Number: 24JBV645; 14) DYNJ63696, UDI-DI: 10193489754704(each), 40193489754705(case), Lot Number: 24JBV846; 15) DYNJ68328, UDI-DI: 10193489823554(each), 40193489823555(case), Lot Number: 24JBW152; 16) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Number: 24JBW480; 17) DYNJ63753, UDI-DI: 10193489757330(each), 40193489757331(case), Lot Numbe
10889942437078, 40889942437079, 10193489243826, 40193489243827, 10889942213542, 40889942213543, 10195327444075, 40195327444076, 10193489318128, 40193489318129, 10195327345075, 40195327345076, 10884389871652, 40884389871653, 10195327468828, 40195327468829, 10193489672763, 40193489672764, 10193489238655, 40193489238656, 10193489754704, 40193489754705, 10193489823554, 40193489823555, 10193489757330, 40193489757331, 10193489916355, 40193489916356, 10889942116553, 40889942116554, 10195327631321, 40195327631322, 10198459166037, 40198459166038, 10884389380406, 40884389380407, 10193489288940, 40193489288941, 10195327209704, 40195327209705
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.