Intravenous Sodium Chloride Injection Recalled Due to Sterility and Leakage Risk
B Braun Medical Inc. is recalling 23,100 containers of 0.9% Sodium Chloride Injection nationwide due to lack of sterility assurance and potential fluid leakage at weld sites. The intravenous medication may become contaminated.
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: This is an FDA Class II recall of an intravenous medication with documented lack of sterility assurance and potential for contamination. While no illnesses or injuries are reported in the source, the potential for serious patient harm from non-sterile intravenous medications warrants High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
B Braun Medical Inc. is recalling approximately 23,100 containers of 0.9% Sodium Chloride Injection USP (1000mL Excel Container) distributed nationwide. The affected product is from Lot #J5C919 with an expiration date of 08/31/2027. The recall was initiated due to lack of assurance of sterility and potential for fluid leakage at weld sites within the container.
Sodium Chloride Injection is an intravenous medication administered directly into the bloodstream. Lack of sterility assurance and potential fluid leakage may result in product contamination, which could pose a significant health risk to patients receiving the injection.
Healthcare providers with the affected product should immediately cease use and verify whether the product was dispensed or administered to any patients.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Injectable
- Hazard
- sterility-compromise
- fluid-leakage
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.
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