FDA Drug recall D-0517-2020
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
- FDA Drug
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29 by Baxter Healthcare, citing lack of Assurance of Sterility: Product has the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0517-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-19 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Reason
Lack of Assurance of Sterility: Product has the potential to leak.
Identifiers
| ndc | 0338-0047-24 |
|---|---|
| ndc | 0338-0047-27 |
| ndc | 0338-0047-29 |
| code_info | Lot #: Y309971, Y309971A, Exp. date 6/30/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0517-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.