Recalls / Class II
Class IID-0353-2025
Product
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0264-2201
- FDA application
- NDA016733
- Affected lot / code info
- Lot # J4K936, Exp 7/31/2027
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 Mcgaw Ave, N/A, Irvine, California 92614-5841
Distribution
- Quantity
- 32,256 Bottles
- Distribution pattern
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2025-03-31
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0353-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.