Sodium chloride injection containers recalled over potential fluid leakage at weld site
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable solution is a potential harm and no injuries are reported.
Plain-English summary
0.9% Sodium Chloride Injection USP, L 8000, in 1000 mL Excel containers, NDC 0264-7800-00, is being recalled. The prescription-only product is a sterile, non-pyrogenic, single dose container made by B. Braun Medical Inc. of Bethlehem, Pennsylvania. The affected product is lot J5C919 with an expiry of 08/31/2027, and the recall covers 23,100 containers distributed nationwide.
The recall was issued for lack of assurance of sterility, because of the potential for fluid leakage at one of the weld sites on the container. The FDA classified the action as Class II.
Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow B. Braun's instructions for return or replacement.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Solution
- Affected units
- 23,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: J5C919
- Exp. 08/31/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by B BRAUN MEDICAL INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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