United StatesB. Braun Medical 3000 mL and 2000 mL bags — including Sterile Water for Injection USP (3000 mL, NDC 0264-7385-60), Dextrose Injection USP 70% (2000 mL, NDC 0264-7387-50), 0.9% Sodium Chloride Irrigation USP (3000 mL, NDC 0264-7388-60), and Lactated Ringer’s Irrigation (3000 mL, NDC 0264-7389-60) — and specific lots and expiry dates listed by the firm are recalled. They were recalled because of lack of assurance of sterility and potential for leakage from the diaphragm port once the foil is removed.
What's being recalled
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Recalling firm: B Braun Medical Inc, Allentown, PA, United States.
How to identify it
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. Lot # J5H166, J5H167, Exp Date: 30NOV2026. Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
The hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)