CLASS II Device recall · Reported 14 Apr 2021 · FDA Enforcement Report

Amicus Exchange Kit Therapeutics recalled by Fenwal

Fenwal is recalling Amicus Exchange Kit Therapeutics, distributed nationwide in the US. The recall was initiated on 25 Feb 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)

Quantity recalled24 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1345-2021
FDA event ID: 87407
Recalling firm: Fenwal, Lake Zurich, IL
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2021
FDA classified: 2 Apr 2021
Reported: 14 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

25 Feb 2021	Recall initiated by company
2 Apr 2021	Classified by FDA	+36 days
14 Apr 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Where it was distributed

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.

Nationwide California Colorado Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota North Carolina New Jersey New Mexico Nevada New York Ohio Pennsylvania Tennessee

Questions about this recall

Is Amicus Exchange Kit Therapeutics recalled?

Yes. Fenwal recalled Amicus Exchange Kit Therapeutics on 25 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-1345-2021.

Why was it recalled?

Which lots are affected?

Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fenwal

All 10

Reported	Class	Recall	Company	Reason	Where
22 Mar 2023Device	CLASS II	Amicus MNC Apheresis Kit Double Needle recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
22 Mar 2023Device	CLASS II	Amicus Exchange Kit Therapeutics recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Amicus MNC Apheresis Kit - Double Needle recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
14 Apr 2021Device	CLASS II	Amicus Exchange Kit recalled by Fenwal	Fenwal	Packaging Defects	Nationwide
21 Aug 2019Device	CLASS I	Volumat MC Agilia US, Infusion Pump recalled by Fenwal	Fenwal	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide