D-0351-2019 Class II Terminated
FDA drug recall D-0351-2019 was initiated by Baxter Healthcare Corporation on Jan 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. The recall status is terminated (terminated Apr 29, 2020). Affected quantity: 29,370 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 16, 2019
- Initiation Date
- Jan 2, 2019
- Termination Date
- Apr 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,370 bags
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.
Reason for recall
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Distribution pattern
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Code information
Lot #: Y281477, Expiry: 02/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0351-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026