Recall Z-1343-2021— Fenwal Inc
Class II · Terminated
Class II FDA medical device recall by Fenwal Inc, initiated 2021-02-25, terminated 2023-04-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Amicus MNC Apheresis Kit - Double Needle - 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
Product description
Amicus MNC Apheresis Kit - Double Needle - 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.