Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviole
FDA device recall Z-0595-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Therakos, Inc.
- Reason for recall
- There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.
- Action taken
- Therakos sent an "URGENT PRODUCT CORRECTION NOTIFICATION" dated September 1, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Additionally, a Confirmation of Receipt was attached to the letter for customers to complete and return. Contact Therakos Technical Support at 1-877-865-6850 for questions regarding this notice.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNR
- Quantity affected
- 49 USA, 65 Foreign
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-09-01
- Date posted
- 2012-01-11
- Date terminated
- 2014-03-27
- Location
- Raritan, NJ
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