Drug recall
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation…
FDA recall event 83340 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 83340 |
|---|---|
| Recall numbers | D-1514-2019 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Drugs |
| Products | 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Bags have potential to leak. |
| Initiation date | Jul 18, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Apr 19, 2021 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: