Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
FDA device recall Z-1254-2023 · posted 2023-03-15 · Open, Classified
Recall details
- Recalling firm
- Fenwal Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LKN
- Quantity affected
- 1,614 units
- Distribution
- Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
- Date initiated
- 2023-02-14
- Date posted
- 2023-03-15
- Location
- Lake Zurich, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615) | Fresenius Kabi USA,Llc | 2018-12-04 |