Drug recall
Baxter Fenwal Amicus Separator Apheresis Device
FDA recall event 46199 · Class II · Fenwal Inc
Key facts
| Event ID | 46199 |
|---|---|
| Recall numbers | B-0908-08 |
| Recalling firm | Fenwal Inc |
| Product type | Biologics |
| Products | Baxter Fenwal Amicus Separator Apheresis Device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fenwal failed to provide users participating in the Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) program with the chart listing the minimum plasma volumes for… |
| Initiation date | May 8, 2007 |
| Termination date | Apr 28, 2008 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3006329594 |
At a glance
- 1–9 Products in this recall
- None 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