Sodium Chloride Injection Recalled for Sterility Assurance Defect
B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to potential sterility failures caused by pinholes in finger boxes during manufacturing. The defect may allow leaks and compromise the sterile nature of the intravenous medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility defect in an intravenous drug product with a large distribution footprint (187,656 containers nationwide). Loss of sterility in injectable medications poses a serious risk of infection; although no illnesses are reported in the source text, the structural manufacturing defect directly affects the safety-critical sterility assurance of the product.
Plain-English summary
B Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP, 500 mL in excel containers, distributed nationwide. The affected lots are J4L260, J4L261, J4L270, J4L271, and J4L280, with an expiration date of 2/28/2027. A total of 187,656 containers are included in this recall.
The recall is due to lack of assurance of sterility. Pinholes were identified in the finger boxes used during the Form Fill Seal manufacturing process, which can result in leaks. This defect may compromise the sterile integrity of the intravenous injection product.
Healthcare providers and patients currently using or with stock of the recalled lots should discontinue use and contact their supplier or B Braun Medical Inc. for guidance on disposition and replacement product. Patients should consult with their healthcare provider regarding any concerns about doses already administered.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Injectable / Intravenous
- Affected units
- 187,656
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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