Lower riskMedical device recall · FDA · Published February 14, 2023
Fenwal Amicus Exchange Kit Recall: Risk of Stress Leaks in Centrifuge Packs
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.
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Contact the company
📍Recalling firmFenwal Inc3 Corporate Dr Ste 300 · Lake Zurich, IL 60047-8930
“Fenwal Amicus Exchange Kit Recall: Risk of Stress Leaks in Centrifuge Packs.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58894-fenwal-amicus-exchange-kit-recall-risk-of-stress-leaks-in. Based on FDA recall #Z-1255-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2023%22&limit=1).
The FDA announced on Feb. 14, 2023, that Fenwal Inc voluntarily recalled Amicus Exchange Kit Therapeutics due to potential centrifuge pack stress leaks. The agency issued recall number Z-1255-2023 for the Class II device.
How to tell if you have it
Brand: Fenwal
Product: Amicus Exchange Kit Therapeutics
Component of Amicus Separator multiprocedural apheresis platform
The recall addresses the potential for centrifuge packs to develop a stress leak in certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator, according to the FDA.
Context
GovInfoNow's records show Fenwal Inc has 4 other recalls on record since 2019-02-11. Other recent recalls of similar products include Medline Medical Kits Recalled Due to Cracked Adhesive Risk (2025-12-12), Medline Nerve Block Tray 2 Kits Recall: Cracked Adhesive Risk (2025-12-12), and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12).
How to tell if you have this one
Check for batch numbers FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, or FA22K21065 on the product label. The product code is X6R2349 with UDI 04086000101950.
Brand
Fenwal
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Recall number
Product, codes & lots
Quantity
Z-1254-2023
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform; Product Code X6R2326; UDI: 04086000100144; Batch Numbers: FA22G25121, FA22H22134, FA22I26141, FA22J25225, FA22J31074. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.
1,614 units
Z-1255-2023
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform; Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.
6,564 units
Based on the official FDA remedy
What to do — step by step
Check Product Batch
Verify the batch number on the product label to see if it matches the affected numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, or FA22K21065.
Contact Manufacturer
Reach out to Fenwal Inc for guidance on next steps if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1255-2023 (February 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1255-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.