Why it was recalled
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Product description
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Lot numbers, UPCs & expiration codes
Lot #: Y281477, Expiry: 02/2020
Where it was sold
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
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-0351-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 2, 2019
- FDA report date
- Jan 16, 2019
- Quantity
- 29,370 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0351-2019, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81881
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: Y281477, Expiry: 02/2020
- Postal code
- 60015-4625
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0351-2019
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 29,370 bags
- Termination date
- Apr 29, 2020
- Reason for recall
- Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
- Distribution pattern
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
- Recall initiation date
- Jan 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2019