0 — Class II drug recall D-0517-2020
Terminated recall by Baxter Healthcare Corporation, reported 2019-11-27, distributed nationwide. Lack of Assurance of Sterility: Product has the potential to leak.
| Recall number | D-0517-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2019-11-20 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2021-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 22,336 bags |
| Reason classes | sterility, packaging |
| NDC | 00338-0047, 00338-0047-24, 00338-0047-27, 00338-0047-29 |
| Lot numbers | Y309971, Y309971A |
| Expiration dates | 2021-06-30 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0517-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.