Intravenous Sodium Chloride Injection Recall for Potential Bag Leakage
B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.
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 3/5 (High).
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: FDA Class II recall involving a critical healthcare product (intravenous injection) where sterility is essential for patient safety. The recall is precautionary; no illnesses or injuries have been reported in the source material. The hazard is potential sterility compromise due to bag leakage rather than confirmed contamination.
Plain-English summary
B. Braun Medical, Inc. is recalling 0.9% Sodium Chloride Injection USP (saline solution) in 1000 mL single-dose bags. The affected product carries lot number 0061832446, with expiration date October 31, 2024. The NDC (National Drug Code) is 0264-5802-00, and 756 bags have been distributed.
The FDA classified this as a Class II recall due to a lack of sterility assurance. Bags have the potential to leak, which could compromise the sterility of the solution and create a risk of contamination for patients receiving intravenous infusions.
The affected product was distributed to healthcare facilities in Florida, New Jersey, and Pennsylvania. Patients who received this product are urged to consult their healthcare provider. Healthcare facilities that received this product should stop distribution and quarantine remaining inventory.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Drug — Intravenous Solution
- Affected units
- 756
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 (1)
- Lot: 0061832446 Exp. 31 Oct 2024
Distribution
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