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: 11889 units Lot/code info: 1) DYNJ61594, UDI-DI: 10193489586121(each), 40193489586122(case), Lot Number: 24IBF062; 2) DYNJ31798D, UDI-DI: 10195327609078(each), 40195327609079(case), Lot Number: 24IBF219; 3) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBF751; 4) DYNJ49386A, UDI-DI: 10889942292882(each), 40889942292883(case), Lot Number: 24IBF768; 5) DYNJ51781G, UDI-DI: 10198459045974(each), 40198459045975(case), Lot Number: 24IBG614; 6) DYNJ54474C, UDI-DI: 10195327698560(each), 40195327698561(case), Lot Number: 24IBG988; 7) DYNJ46311F, UDI-DI: 10193489933185(each), 40193489933186(case), Lot Number: 24IBH023; 8) DYNJ65348, UDI-DI: 10193489268881(each), 40193489268882(case), Lot Number: 24IBH081; 9) DYNJ37322I, UDI-DI: 10193489961553(each), 40193489961554(case), Lot Number: 24IBH579; 10) DYNJ69926A, UDI-DI: 10195327153601(each), 40195327153602(case), Lot Number: 24IBH589; 11) DYNJ39903, UDI-DI: 10884389842072(each), 40884389842073(case), Lot Number: 24IBH647; 12) DYNJ47816B, UDI-DI: 10193489370256(each), 40193489370257(case), Lot Number: 24IBH806; 13) SYNJ10253B, UDI-DI: 10193489373592(each), 40193489373593(case), Lot Number: 24IBH821; 14) DYNJ31169C, UDI-DI: 10889942373468(each), 40889942373469(case), Lot Number: 24IBK285; 15) DYNJ06622J, UDI-DI: 10889942725649(each), 40889942725640(case), Lot Number: 24IBQ232; 16) DYNJ83390, UDI-DI: 10195327262914(each), 40195327262915(case), Lot Number: 24IBQ640; 17) DYNJ33236, UDI-DI: 10884389260227(each), 40884389260228(case), Lot Nu
10193489586121, 40193489586122, 10195327609078, 40195327609079, 10193489933185, 40193489933186, 10889942292882, 40889942292883, 10198459045974, 40198459045975, 10195327698560, 40195327698561, 10193489268881, 40193489268882, 10193489961553, 40193489961554, 10195327153601, 40195327153602, 10884389842072, 40884389842073, 10193489370256, 40193489370257, 10193489373592, 40193489373593, 10889942373468, 40889942373469, 10889942725649, 40889942725640, 10195327262914, 40195327262915, 10884389260227, 40884389260228, 10193489429749, 40193489429740, 10198459022111, 40198459022112, 10195327242343, 40195327242344, 10195327695989, 40195327695980
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.