D-0957-2017 Class II Terminated
FDA drug recall D-0957-2017 was initiated by Baxter Healthcare Corporation on Jul 6, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Customer complaints for leaking bags. The recall status is terminated (terminated Apr 29, 2020). Affected quantity: 131,904 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 19, 2017
- Initiation Date
- Jul 6, 2017
- Termination Date
- Apr 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 131,904 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.
Reason for recall
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Distribution pattern
Nationwide in USA
Code information
Lot: Y229153, Exp 09/30/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0957-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026