Recall Z-1255-2023 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Fenwal Inc
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
| Date | Mar 15, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues. |
| Quantity | 6,564 units |
| Distribution | Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Fresenius Kabi USA,Llc, Dec 4, 2018 |