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Terminated

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

FDA Recall Z-1654-2010 · Posted 2010-05-26

Recalling FirmTherakos Inc
Recall StatusTerminated
Product CodeLNR
Date Initiated2010-03-29
Date Terminated2013-07-18
Product Quantity280 units in US (1 sales unit contains 3 kits each)

Reason for Recall

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

Firm 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 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

Distribution Pattern

Nationwide Distribution, and Canada and Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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