Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;

FDA device recall Z-1654-2010 · posted 2010-05-26 · Terminated

Recall details

Recalling firm

Therakos Inc

Reason for recall

Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System

Action taken

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 additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LNR

Quantity affected

280 units in US (1 sales unit contains 3 kits each)

Distribution

Nationwide Distribution, and Canada and Germany

Date initiated

2010-03-29

Date posted

2010-05-26

Date terminated

2013-07-18

Location

Raritan, NJ