Recall Z-1343-2021 ยท GKT Separator, Automated, Blood Cell, Diagnostic
Fenwal Inc
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
| Date | Feb 25, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | A Recall notification letter titled, "URGENT - Medical Device Recall Amicus MNC Apheresis/Exchange Disposable Kits" and form titled, Amicus Therapeutic Kits Customer Reply Form were sent to consignees on 02/25/2021 via Fed Ex Overnight Express. The consignee requested their customers to: 1) Discontinue use of the affected products immediately by checking their inventory and quarantining all affected product at their facility. They were also informed to contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 for replacement kits to ensure additional procedures can continue. 2) Inform |
| Quantity | 4488 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.