Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation a
FDA device recall Z-2839-2011 · posted 2011-07-19 · Terminated
Recall details
- Recalling firm
- Therakos Inc
- Reason for recall
- Cellex Procedural kits may have minor tears in their Tyvek covers.
- Action taken
- Therakos, Inc. sent an "Important Product Notification" dated December 2, 2010 to all affected customers. The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form. For additional information contact Therakos Customer Technical Services at 877-865-6850.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LNR
- Quantity affected
- 110 units
- Distribution
- Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
- Date initiated
- 2010-12-02
- Date posted
- 2011-07-19
- Date terminated
- 2015-02-19
- Location
- Raritan, NJ
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