Fenwal recalls Amicus MNC A: Double Needle kits with specific batch numbers due to potential stress leaks in centrifuge packs during use. Affected units may cause injury if not properly managed.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Fenwal is recalling Amicus MNC Apheresis Kit Double Needle components because certain batches may develop stress leaks in the centrifuge packs. This could lead to injury if the leak causes a sudden release of fluid during medical procedures.
The centrifuge packs in certain batches of the Amicus MNC Apheresis Kit Double Needle can develop a stress leak. This leak may cause a sudden release of fluid during medical procedures, potentially leading to injury if not properly managed.
Patients using the Amicus Separator multiprocedural apheresis platform with the affected batch numbers are most at risk. Healthcare providers administering these kits may also be impacted.
Check the batch numbers on the product label: FA22G25121, FA22H22134, FA22I26141, FA22J25225, or FA22J31074. The product is part of the Amicus Separator multiprocedural apheresis platform and has a specific UDI code.
Look for batch numbers FA22G25121, FA22H22134, FA22I26141, FA22J25225, or FA22J31074 on the product label.
Certain batches of the Amicus MNC Apheresis Kit Double Needle may develop a stress leak in the centrifuge packs, which could lead to injury during medical procedures.
Check the batch numbers on the product label: FA22G25121, FA22H22134, FA22I26141, FA22J25225, or FA22J31074.
The recall does not specify a remedy, so contact Fenwal directly for guidance on next steps.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1254-2023 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1254-2023 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.
