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.
Take action
Contact the company
📍Recalling firmFenwal Inc3 Corporate Dr Ste 300 · Lake Zurich, IL 60047-8930
“Fenwal Amicus Exchange Kit Recall: Leaking Centrifuge Packs During Blood Collection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63224-fenwal-amicus-exchange-kit-recall-leaking-centrifuge-packs-during-blood. Based on FDA recall #Z-1344-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1344-2021%22&limit=1).
The FDA announced on Feb. 25, 2021, that Fenwal Inc is recalling Amicus Exchange Kits due to leaking centrifuge packs during use. The agency said the defect poses a blood leak hazard at the boot, elbow, or separation chamber channel.
Distribution: US Nationwide in GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, OH, NY, FL
The hazard
According to the FDA, some lots have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is described as a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
Context
GovInfoNow's records show Fenwal Inc has issued four other recalls since Feb. 11, 2019. On Feb. 14, 2023, Fenwal recalled Amicus MNC Apheresis Kits due to potential stress leaks in centrifuge packs. Other recent recalls of similar products include ICU Medical Pulsator Arterial Blood Sampling Kit Recall (Dec. 19, 2025), Medline Dialysis Kits Recall (Jan. 8, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026).
How to tell if you have this one
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).
Brand
Fenwal
Category
Medical device
FDA recall event · 3 products
All 3 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
Terminated
Distribution
US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.
Recall number
Product, codes & lots
Quantity
Z-1343-2021
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.; Product Code X6R2326; UDI: 04086000100144; Batch Numbers FA20E25234 ((Exp. 05/31/2022), FA20F23120 (Exp. 06/30/2022), FA20I21268 (Exp. 09/30/2022), and FA20J19246 (Exp. 10/31/2022).
4488 units
Z-1344-2021
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.; Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022)
2466 units
Z-1345-2021
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.; Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
24 units
Based on the official FDA remedy
What to do — step by step
Check Kit Batch Number
Look for the batch numbers FA20F08147, FA20H12145, or FA20J27157 on the Amicus Exchange Kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1344-2021 (February 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1344-2021 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.