Fenwal recalls Amicus Exchange Kit Therapeutics due to potential stress leaks in centrifuge packs for certain batch numbers. Affected units may require replacement to prevent equipment damage.
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 specific batches of Amicus Exchange Kit Therapeutics because centrifuge packs could develop stress leaks. This could lead to equipment damage if the kit is used without replacement.
Centrifuge packs in certain batches of the Amicus Exchange Kit may develop stress leaks during use. This could cause equipment damage but does not pose a direct risk to patient safety.
Healthcare professionals using the Amicus Separator multiprocedural apheresis platform with the affected batch numbers are most at risk. The recall affects specific product batches sold in the U.S.
Check for batch numbers FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, or FA22K21065 on the product label. The product code is X6R2349 with UDI 04086000101950.
Verify the batch number on the product label to see if it matches the affected numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, or FA22K21065.
Reach out to Fenwal Inc for guidance on next steps if the product is affected.
The affected batch numbers are FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, and FA22K21065.
Check the batch number on the product label. The affected batch numbers are FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, or FA22K21065.
The recall record does not specify a remedy, so contact Fenwal Inc for guidance.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1255-2023 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1255-2023 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.
