Why it was recalled
Presence of Particulate Matter
Product description
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
Lot numbers, UPCs & expiration codes
Lot # J4K936, Exp 7/31/2027
Where it was sold
Product was distributed to 12 distributors who may have further distributed the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0353-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 31, 2025
- FDA report date
- Apr 16, 2025
- Quantity
- 32,256 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0353-2025, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96605
- Address
- 2525 Mcgaw Ave
- Code information
- Lot # J4K936, Exp 7/31/2027
- Postal code
- 92614-5841
- Report date
- Apr 16, 2025
- Product type
- Drugs
- Recall number
- D-0353-2025
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 32,256 Bottles
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
- Recall initiation date
- Mar 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2025