FDA Recall D-0353-2025
B. Braun Medical Inc · Irvine, CA
Class II Ongoing 409 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Presence of Particulate Matter
Recall record
- Recall number
D-0353-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
- Recall initiated
- 2025-03-31
- Classified by FDA Center
- 2025-04-08
- FDA published
- 2025-04-16
- Recalling firm
- B. Braun Medical Inc
- Firm location
- Irvine, CA
Drug identification
- Brand name(s)
- SODIUM CHLORIDE
- Generic name(s)
- SODIUM CHLORIDE
- Manufacturer(s)
- B. Braun Medical Inc.
- NDC(s)
0264-2201- Route(s)
- IRRIGATION
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.