Fenwal recalls Amicus Exchange kits with leaking centrifuge packs that could cause blood leaks during blood component collection procedures. Affected kits have specific batch numbers and expiration dates.
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.
Fenwal is recalling certain Amicus Exchange kits that have leaking centrifuge packs during blood collection procedures. This defect could lead to blood leaks during therapeutic use, potentially causing injury.
The centrifuge packs in some lots leak blood at the boot, elbow, or channel during therapeutic procedures. This leak could cause blood to escape during the collection process, potentially leading to injury.
People using the Amicus Exchange kits for blood component collection, especially those with specific batch numbers and expiration dates. Those performing therapeutic procedures are most at risk.
Check for batch numbers FA20E25150 (expiring 05/31/2022) or FA20I22142 (expiring 09/30/2022) on the Amicus Exchange kits. These kits are intended for blood component collection and mononuclear cell therapy.
Look for batch numbers FA20E25150 (exp. 05/31/2022) or FA20I22142 (exp. 09/30/2022) on the Amicus Exchange kits.
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during therapeutic procedures, causing blood leaks at the boot, elbow, or channel.
Batch numbers FA20E25150 (expiring 05/31/2022) and FA20I22142 (expiring 09/30/2022).
The recall does not specify a stop-use instruction; affected kits should be checked for batch numbers and handled with caution.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2021 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1345-2021 from Fenwal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
