Recall Z-1654-2010 ยท LNR System, Photopheresis, Extracorporeal
Therakos Inc
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
| Date | May 26, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| Reason | Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System |
| Root cause | Nonconforming Material/Component |
| Action | On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter. On May 7, 2010 all direct end use and distributor consignees were notified of the addit |
| Quantity | 280 units in US (1 sales unit contains 3 kits each) |
| Distribution | Nationwide Distribution, and Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.