Recall Z-1344-2021— Fenwal Inc

Name: FDA recall Z-1344-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-25

Class II · Terminated

Class II FDA medical device recall by Fenwal Inc, initiated 2021-02-25, terminated 2023-04-18. It names one FDA 510(k) clearance: K180615. Product: Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.. 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..

Recalling firm: Fenwal Inc
Classification: Class II
Status: Terminated
Initiated: 2021-02-25
Terminated: 2023-04-18
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 - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Reason for recall

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.

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