Sodium Chloride Irrigation Solution Recalled for Particulate Matter
B. Braun Medical is recalling 0.9% sodium chloride irrigation solution (500 mL) in lot J4K936 due to the presence of particulate matter. The product was distributed nationwide through 12 distributors.
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: FDA Class II recall for a risk-of-harm product. Particulate matter in irrigation solution used on sterile medical fields presents a risk of infection or foreign body complications. No illnesses or injuries are reported in the source material, placing this at the high end of risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical Inc is recalling 0.9% Sodium Chloride Irrigation USP, an isotonic solution for irrigation supplied in 500 mL plastic irrigation containers. The affected product is lot number J4K936 with an expiration date of July 31, 2027, and carries NDC code 0264-2201-10. Approximately 32,256 bottles are involved in this recall.
The recall has been issued due to the presence of particulate matter in the product. This contamination could pose a risk to patients using the solution for irrigation during medical procedures.
The affected product was distributed to 12 distributors, who may have distributed it further nationwide. Patients and healthcare providers who have received this product should discontinue use and consult with B. Braun Medical Inc or their healthcare provider for guidance. Those with questions about this recall should contact the manufacturer directly.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Irrigation Solution
- Hazard
- particulate-matter
- contamination
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 # J4K936
- Exp 7/31/2027
Distribution
Distributed nationwide across the United States.
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