FDA Medical Device Recalls (openFDA)
Fenwal Inc: Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Recall number
- Z-1255-2023
- Recalling firm
- Fenwal Inc
- Product
- Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Status
- Open, Classified
- Initiated
- 2023-02-14
- Posted
- 2023-03-15
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.
- Quantity
- 6,564 units
- Distribution
- Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K180615"]
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 3004548776
- Firm city
- Lake Zurich
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28