Medical Device Apheresis Kit Recalled Due to Stress Leak Risk
Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with potential for functional failure (stress leak), but no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Fenwal Inc is recalling 6,564 units of Amicus Exchange Kit Therapeutics, a component of the Amicus Separator multiprocedural apheresis platform. Certain lots of both Amicus Exchange kits and Amicus MNC Apheresis kits are affected due to the potential for centrifuge packs to develop a stress leak.
The affected lot numbers are FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, and FA22K21065. The devices were distributed nationwide and internationally to France, Korea, Taiwan, Colombia, India, Brazil, Germany, and Canada.
No illnesses or injuries have been reported in connection with this issue. The potential stress leak in the centrifuge pack could affect the proper functioning of the device.
Customers in possession of affected devices should contact Fenwal Inc for further instructions regarding their inventory.
The recalled product
- Product
- Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Manufacturer
- Fenwal Inc
- Hazard
- stress-leak
- device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
Distribution
Distributed nationwide across the United States.
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