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: 354 units Lot/code info: 1) DYNJ41856C, UDI-DI: 10195327429010(each), 40195327429011(case), Lot Number: 24JBM711; 2) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24JBN788; 3) DYNJ50629M, UDI-DI: 10198459146985(each), 40198459146986(case), Lot Number: 24JBW674; 4) DYNJ40040C, UDI-DI: 10889942683970(each), 40889942683971(case), Lot Number: 24KBC507; 5) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24KBC655
10195327429010, 40195327429011, 10195327494094, 40195327494095, 10198459146985, 40198459146986, 10889942683970, 40889942683971
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.