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FDA · Drugs ·

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags recall

B BRAUN MEDICAL INC recalled 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags on April 29, 2026 because of lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

What's recalled

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.

Quantity: 124,244 bags

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
B BRAUN MEDICAL INC, Allentown, PA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0497-2026
Source
U.S. Food and Drug Administration

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