0 — Class I drug recall D-0957-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-06-15, distributed nationwide. Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary con
| Recall number | D-0957-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-12-15 |
| Classified | 2016-06-06 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2022-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 255,852 viaflex |
| Reason classes | foreign material, specification failure |
| NDC | 00338-0043, 00338-0043-03, 00338-0043-04, 00338-0049, 00338-0049-01, 00338-0049-02, 00338-0049-03, 00338-0049-04, 00338-0049-10, 00338-0049-11, 00338-0049-18, 00338-0049-31, 00338-0049-38, 00338-0049-41, 00338-0049-48 |
| Lot numbers | 11/16, C980227 |
Product
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
Reason for recall
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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-0957-2016. 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.