Sodium Chloride Injection recalled for packaging sterility defects
B Braun Medical is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to pinholes in packaging that compromise sterility assurance in this intravenous product.
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: The defect creates a potential for compromised sterility in an intravenous product. Although no illnesses or injuries have been reported and no contamination has been confirmed, the loss of sterility assurance in IV medications presents risk of serious harm if contamination occurs, supporting a High severity rating per the rubric.
Plain-English summary
B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP, 500 mL per container. The recalled product includes specific lot numbers: J4L260, J4L261, J4L270, J4L271, and J4L280, with an expiration date of February 28, 2027.
The recall was initiated due to a manufacturing defect discovered during the Form Fill Seal packaging process. Pinholes were identified in the finger boxes used during packaging, resulting in leaks that compromise the sterile barrier of the product.
The affected containers have been distributed nationwide throughout the United States. The product is a prescription intravenous injection administered in medical and healthcare settings.
Healthcare providers and facilities in possession of the affected lot numbers should be aware of this recall and take appropriate action regarding the use of these containers.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Injectable
- Hazard
- packaging-defect
- sterility-compromise
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 (6)
- Lot #: J4L260
- J4L261
- J4L270
- J4L271
- J4L280
- Exp 2/28/2027
Distribution
Distributed nationwide across the United States.
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