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: 14760 units Lot/code info: 1) DYNJ84990, UDI-DI: 10195327444068(each), 40195327444069(case), Lot Number: 24IBE926; 2) DYNJ45711B, UDI-DI: 10193489856149(each), 40193489856140(case), Lot Number: 24IBE981; 3) DYNJ45266B, UDI-DI: 10193489852417(each), 40193489852418(case), Lot Number: 24IBF031; 4) DYNJ80737B, UDI-DI: 10198459050855(each), 40198459050856(case), Lot Number: 24IBF165; 5) DYNJ67785A, UDI-DI: 10193489945638(each), 40193489945639(case), Lot Number: 24IBG441; 6) DYNJ49675F, UDI-DI: 10198459113529(each), 40198459113520(case), Lot Number: 24IBG617; 7) DYNJ0579176B, UDI-DI: 10889942429844(each), 40889942429845(case), Lot Number: 24IBG732; 8) DYNJ23615D, UDI-DI: 10193489587012(each), 40193489587013(case), Lot Number: 24IBG752; 9) DYNJ44752D, UDI-DI: 10195327322342(each), 40195327322343(case), Lot Number: 24IBG844; 10) DYNJ83155, UDI-DI: 10195327236854(each), 40195327236855(case), Lot Number: 24IBH261; 11) DYNJ83423, UDI-DI: 10195327265410(each), 40195327265411(case), Lot Number: 24IBH595; 12) DYNJ64257C, UDI-DI: 10195327449445(each), 40195327449446(case), Lot Number: 24IBH738; 13) DYNJ30587I, UDI-DI: 10198459078866(each), 40198459078867(case), Lot Number: 24IBM219; 14) DYNJ58655B, UDI-DI: 10198459027475(each), 40198459027476(case), Lot Number: 24IBQ285; 15) DYNJ49308F, UDI-DI: 10195327631178(each), 40195327631179(case), Lot Number: 24IBQ350; 16) DYNJ46736B, UDI-DI: 10889942559312(each), 40889942559313(case), Lot Number: 24IBQ975; 17) DYNJ27547B, UDI-DI: 10198459093616(each), 40198459093617(case), Lo
10195327444068, 40195327444069, 10193489856149, 40193489856140, 10193489852417, 40193489852418, 10198459050855, 40198459050856, 10193489945638, 40193489945639, 10198459113529, 40198459113520, 10889942429844, 40889942429845, 10193489587012, 40193489587013, 10195327322342, 40195327322343, 10195327236854, 40195327236855, 10195327265410, 40195327265411, 10195327449445, 40195327449446, 10198459078866, 40198459078867, 10198459027475, 40198459027476, 10195327631178, 40195327631179, 10889942559312, 40889942559313, 10198459093616, 40198459093617, 10195327464806, 40195327464807, 10195327428983, 40195327428984, 10888277816879, 40888277816870
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.