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Open, Classified

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

FDA Recall Z-1254-2023 · Posted 2023-03-15

Recalling FirmFenwal Inc
Recall StatusOpen, Classified
Product CodeLKN
Date Initiated2023-02-14
Product Quantity1,614 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc · 2018-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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