Why it was recalled
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Product description
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Lot numbers, UPCs & expiration codes
Lot number: C903799, Exp 05/15
Where it was sold
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-1276-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 11, 2014
- FDA report date
- May 7, 2014
- Quantity
- 27,169 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1276-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67608
- Address
- 1 Baxter Pkwy
- Code information
- Lot number: C903799, Exp 05/15
- Postal code
- 60015-4625
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1276-2014
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 27,169 containers
- Termination date
- Jul 22, 2015
- Reason for recall
- Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
- Distribution pattern
- Nationwide.
- Recall initiation date
- Feb 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2014