Recall archive / FDA device enforcement
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform — FDA record Z-1255-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 14, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Fenwal Inc
- Quantity
- 6,564 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1255-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 22, 2023
- Recall initiation date
- Feb 14, 2023
- Center classification date
- Mar 15, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.