Fenwal Inc Recall 87407
Description: Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal Inc Recall 87407 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1344-2021 |
| Event ID | 87407 |
| Event Description | Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL. |
| Quantity | 2466 units |
| Recall Reason | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack. |
| Device Classification | 20210414 |
| Device Code Info | Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022) |
| Center Classification Date | 20210402 |
| Recall Initiation Date | 20210225 |
| Recalling Firm | Fenwal Inc |
| Initial Notification | Letter |
| Similar To |