Fenwal recalls Amicus MNC Apheresis 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 MNC Apheresis kits that may leak blood during blood collection procedures. This defect could lead to blood leaks at the centrifuge pack's connection points, posing a risk during therapeutic use.
The centrifuge packs in some Amicus MNC Apheresis kits can leak blood at the boot, elbow, or channel connections during therapeutic blood collection procedures. This defect occurs only when the kit is used with specific therapeutic protocols on the Amicus Separator.
Patients receiving blood component collection treatments using the Amicus Separator are most at risk. Healthcare providers using the affected kits for therapeutic protocols may also be impacted.
Check for batch numbers FA20E25234 (exp. 05/31/2022), FA20F23120 (exp. 06/30/2022), FA20I21268 (exp. 09/30/2022), or FA20J19246 (exp. 10/31/2022) on the product label. The kits are intended for blood component collection and mononuclear cell collection procedures.
Look for batch numbers FA20E25234, FA20F23120, FA20I21268, or FA20J19246 on the product label.
The centrifuge packs in some Amicus MNC Apheresis kits can leak blood at the boot, elbow, or channel connections during therapeutic blood collection procedures.
Batch numbers FA20E25234 (exp. 05/31/2022), FA20F23120 (exp. 06/30/2022), FA20I21268 (exp. 09/30/2022), and FA20J19246 (exp. 10/31/2022).
The recall record does not specify a remedy.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2021 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1343-2021 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.
