FDA Drugs recall ·
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation… recall
- Recall number
- D-0353-2025
- Date
- (initiated March 31, 2025)
- Company / brand
- B Braun Medical Inc
2525 Mcgaw Ave, Irvine, CA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32,256 Bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Particulate Matter
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # J4K936, Exp 7/31/2027
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0353-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.