Why it was recalled
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Product description
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Lot numbers, UPCs & expiration codes
Batch # J7N912, Exp 10/31/20
Where it was sold
Nationwide in the USA
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-0549-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- 17,360 plastic irrigation containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0549-2018, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79348
- Address
- 2525 McGaw Ave
- Code information
- Batch # J7N912, Exp 10/31/20
- Postal code
- 92614-5841
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0549-2018
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 17,360 plastic irrigation containers
- Termination date
- Jan 23, 2020
- Reason for recall
- Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2018