Drug recall
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
FDA recall event 91704 · Class II · Fenwal Inc
Key facts
| Event ID | 91704 |
|---|---|
| Recall numbers | Z-1254-2023, Z-1255-2023 |
| Recalling firm | Fenwal Inc |
| Product type | Devices |
| Products | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform, Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. |
| Initiation date | Feb 14, 2023 |
| Report date | Mar 22, 2023 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3004548776 |
At a glance
- 1–9 Products in this recall
- 1–9 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: