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: 28127 units Lot/code info: 1) DYNJHTLD02A, UDI-DI: 10193489303360(each), 40193489303361(case), Lot Number: 24IBE784; 2) DYNJ50017B, UDI-DI: 10889942851126(each), 40889942851127(case), Lot Number: 24IBE809; 3) DYNJ68242C, UDI-DI: 10198459091568(each), 40198459091569(case), Lot Number: 24IBF050; 4) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24IBF241; 5) DYNJ42691, UDI-DI: 10888277003507(each), 40888277003508(case), Lot Number: 24IBF320; 6) DYNJ43775C, UDI-DI: 10889942763191(each), 40889942763192(case), Lot Number: 24IBF620; 7) DYNJ54078A, UDI-DI: 10193489528633(each), 40193489528634(case), Lot Number: 24IBF640; 8) DYNJ39493B, UDI-DI: 10889942669998(each), 40889942669999(case), Lot Number: 24IBG032; 9) DYNJ0101397O, UDI-DI: 10195327661663(each), 40195327661664(case), Lot Number: 24IBG201; 10) DYNJ28408J, UDI-DI: 10195327279684(each), 40195327279685(case), Lot Number: 24IBG536; 11) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24IBG574; 12) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24IBG595; 13) DYNJ44532D, UDI-DI: 10195327463700(each), 40195327463701(case), Lot Number: 24IBG706; 14) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBG871; 15) DYNJ63703B, UDI-DI: 10193489883466(each), 40193489883467(case), Lot Number: 24IBH017; 16) DYNJ59621A, UDI-DI: 10193489685374(each), 40193489685375(case), Lot Number: 24IBH300; 17) DYNJ37733B, UDI-DI: 10889942775712(each), 40889942775713(case),
10193489303360, 40193489303361, 10889942851126, 40889942851127, 10198459091568, 40198459091569, 10195327067977, 40195327067978, 10888277003507, 40888277003508, 10889942763191, 40889942763192, 10193489528633, 40193489528634, 10889942669998, 40889942669999, 10195327661663, 40195327661664, 10195327279684, 40195327279685, 10889942684366, 40889942684367, 10195327224479, 40195327224470, 10195327463700, 40195327463701, 10195327621698, 40195327621699, 10193489883466, 40193489883467, 10193489685374, 40193489685375, 10889942775712, 40889942775713, 10193489532890, 40193489532891, 10889942361618, 40889942361619, 10195327130640, 40195327130641
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.