Why it was recalled
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Product description
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Lot numbers, UPCs & expiration codes
Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024
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-0542-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 15, 2023
- FDA report date
- May 3, 2023
- Quantity
- a) 95,448 bags; b) 174,522 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0542-2023, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 91883
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024
- Postal code
- 60015-4625
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0542-2023
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- a) 95,448 bags; b) 174,522 bags
- Reason for recall
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 15, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 24, 2023