Drug recall
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA…
FDA recall event 66389 · Class II · Baxter Healthcare Corp.
Key facts
| Event ID | 66389 |
|---|---|
| Recall numbers | Z-0392-2014 |
| Recalling firm | Baxter Healthcare Corp. |
| Product type | Devices |
| Products | Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incomplete foil seal on one lot of sterile product. |
| Initiation date | Sep 25, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Jul 22, 2014 |
| 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: