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 Amicus Exchange Kits that may leak blood during blood collection procedures. This defect could lead to blood leaks at the centrifuge pack, potentially causing injury if not addressed.
The centrifuge packs in some Amicus Exchange Kits can leak blood at the boot, elbow, or channel during therapeutic blood collection procedures. This leak could cause blood to escape during the procedure, potentially leading to injury if not corrected.
Blood donors and medical professionals using the Amicus Exchange Kit for blood component collection are affected. Those with the specific batch numbers listed are at risk of blood leaks during procedures.
Check the product code X6R2339 on the kit. Affected kits have batch numbers FA20F08147 (expiring 06/07/2022), FA20H12145 (expiring 08/11/2022), or FA20J27157 (expiring 10/26/2022).
Look for the batch numbers FA20F08147, FA20H12145, or FA20J27157 on the Amicus Exchange Kit.
The centrifuge packs in some lots leak blood at the boot, elbow, or channel during therapeutic blood collection procedures.
Batch numbers FA20F08147 (expiring 06/07/2022), FA20H12145 (expiring 08/11/2022), and FA20J27157 (expiring 10/26/2022).
Check the product code X6R2339 and look for the specific batch numbers listed above on the kit.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1344-2021 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1344-2021 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.
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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.
