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U.S. Department of Health and Human Services

Class 2 Device Recall Therakos CellEx Photopheresis System

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 Class 2 Device Recall Therakos CellEx Photopheresis Systemsee related information
Date Initiated by FirmMarch 29, 2010
Date PostedMay 26, 2010
Recall Status1 Terminated 3 on July 18, 2013
Recall NumberZ-1654-2010
Recall Event ID 55300
Product Classification photopheresis kit - Product Code LNR
ProductTherakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
Code Information CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
FEI Number 2523595
Recalling Firm/
Manufacturer		 Therakos Inc
1001 Us Highway 202
Raritan NJ 08869
For Additional Information ContactMr. Joseph Falvo
585-453-3452
Manufacturer Reason
for Recall		Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce280 units in US (1 sales unit contains 3 kits each)
DistributionNationwide Distribution, and Canada and Germany
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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