CLASS II ONGOING Device recall · Reported 22 Mar 2023 · 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 14 Feb 2023 and the FDA has classified it as Class II.
Check your package
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-1255-2023
- FDA event ID
- 91704
- Recalling firm
- Fenwal, Lake Zurich, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Feb 2023
- FDA classified
- 15 Mar 2023
- Reported
- 22 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 14 Feb 2023 | Recall initiated by company | |
| 15 Mar 2023 | Classified by FDA | +29 days |
| 22 Mar 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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. Component of Amicus Separator multiprocedural apheresis platform
Where it was distributed
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Questions about this recall
Is Amicus Exchange Kit Therapeutics recalled?
Yes. Fenwal recalled Amicus Exchange Kit Therapeutics on 14 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1255-2023.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | Amicus MNC Apheresis Kit Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit Therapeutics recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus MNC Apheresis Kit - Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS I | Volumat MC Agilia US, Infusion Pump recalled by Fenwal | Fenwal | Device Malfunction | Nationwide |
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