Recall Z-1255-2023— Fenwal Inc

Name: FDA recall Z-1255-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Class II · Ongoing

Class II FDA medical device recall by Fenwal Inc, initiated 2023-02-14. It names one FDA 510(k) clearance: K180615. Product: Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform. 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..

Recalling firm: Fenwal Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-14
Firm location: Lake Zurich, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc·cleared 2018-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.