D-0517-2020 Class II Terminated
FDA drug recall D-0517-2020 was initiated by Baxter Healthcare Corporation on Nov 19, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Product has the potential to leak. The recall status is terminated (terminated Feb 4, 2021). Affected quantity: 22336 bags.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 27, 2019
- Initiation Date
- Nov 19, 2019
- Termination Date
- Feb 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22336 bags
Product description
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Reason for recall
Lack of Assurance of Sterility: Product has the potential to leak.
Distribution pattern
Nationwide within the United States
Code information
Lot #: Y309971, Y309971A, Exp. date 6/30/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0517-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026