Why it was recalled
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Product description
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
Lot numbers, UPCs & expiration codes
Lot: Y229153, Exp 09/30/18
Where it was sold
Nationwide in 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-0957-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 6, 2017
- FDA report date
- Jul 19, 2017
- Quantity
- 131,904 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0957-2017, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77678
- Address
- 1 Baxter Pkwy
- Code information
- Lot: Y229153, Exp 09/30/18
- Postal code
- 60015-4625
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0957-2017
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 131,904 bags
- Termination date
- Apr 29, 2020
- Reason for recall
- Lack of Assurance of Sterility: Customer complaints for leaking bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
- Distribution pattern
- Nationwide in USA
- Recall initiation date
- Jul 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2017