Recall Z-2839-2011 ยท LNR System, Photopheresis, Extracorporeal
Therakos Inc
Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
| Date | Jul 19, 2011 (initiated Dec 2, 2010) |
| Status | Terminated |
| Reason | Cellex Procedural kits may have minor tears in their Tyvek covers. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 110 units |
| Distribution | Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.