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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 System see related information
Date Initiated by Firm September 01, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 27, 2014
Recall Number Z-0595-2012
Recall Event ID 60628
PMA Number P860003 
Product Classification System, photopheresis, extracorporeal - Product Code LNR
Product Therakos Cellex Photopheresis System
CellexUSA & Cellex.

The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.
Code Information Lot Numbers and Expiration Dates CELLEXUSA 40115 20091201 CELLEXUSA 40117 20090707 CELLEXUSA 40122 120090713 CELLEXUSA 40129 1?0090618 CELLEXUSA 40130 20091103 40133 20091014 CELLEXUSA 40134 20091014 iCELLEXUSA 40136 20091019 ICELLEXUSA CELLEXUSA 40137 20091021 CELLEXUSA 40141 20091201 20091104 40142 iCELLEXUSA 40143 20091208 ICELLEXUSA CELLEXUSA 40151 20091215 - 40152 20100114 CELLEXUSA CELLEXUSA 40154 20100112 20100112 CELLEXUSA 40156 20100112 CELLEXUSA 40158 20100209 CELLEXUSA 40159 - 20100209 CELLEXUSA 40160 40161 20100128 CELLEXUSA 20100209 CELLEXUSA 40162 40163 20100128 CELLEXUSA 40165 20100322 CELLEXUSA 20100401 CELLEXUSA 40166 20101006 CELLEXUSA 40170 40171 20100623 CELLEXUSA 20101022 CELLEXUSA 40172 20100625 CELLEXUSA 40173 40174 20100625 CELLEXUSA 40175 20101029 CELLEXUSA 40176 20101026 CELLEXUSA 40177 20101029 CELLEXUSA 40178 20101130 CELLEXUSA 40179 20100625 CELLEXUSA 40180 20100927 CELLEXUSA 20101130 CELLEXUSA 40181 20101201 CELLEXUSA 40182 20101201 CELLEXUSA 140183 CELLEX 40111 20090327 CELLEX 40112 2009 1005 CELLEX 40113 20090327 CELLEX 40114 20090326 I CELLEX 40116 20090330 CELLEX 40118 20090522 CELLEX 40119 20090423 CELLEX 40120 20090522 CELLEX 40121 20090522 CELLEX 40124 200906 12 CELLEX 40125 20090603 CELLEX 40126 20090612 CELLEX 40127 20090604 CELLEX 40128 2009 1028 CELLEX 40131 20091002 CELLEX 40132 2009 10 15 CEl-LEX 40135 2009 10 15 CELLEX 40138 2009 11 10 CELLEX 40139 2009 1029 CELLEX 40140 2009 1026 CELLEX I 40144 2009 1029 CELLEX 40145 20091029 CELLEX 40147 2009 12 18 CELLEX 140148 2009 12 18 CELLEX 40149 2009 :12 18 rELLEX 40150 2009 12 18 CELLEX 40153 1201002 19 CELLEX 40155 201002 i9 CELLEX 40157 20100219 CELLEX 40164 20100323 CELLEX 40167 20100528 CELLEX 40184 20100920 CELLEX 40185 20100929 CELLEX 40186 2010 1021 CELLEX 40187 2010 10 26 CELLEX 40188 2010 1029 CELLEX 40190 20101223 CELLEX 40191 2010 1223 CELLEXUSA 40189 20100625 CELLEXUSA 40207 20110517 20110531 20110531 20101229 20101229 20110615 20110615 20110809 20110810 20110818 I CELLEXUSA 40208 CELLEXUSA 140209 ICELLEXUSA 40210 CELLEXUSA 40211 CELLEXUSA 40212 CELLEXUSA 40213 CELLEXUSA 40215 CELLEXUSA 40216 CELLEXUSA 40224
Recalling Firm/
Manufacturer		 Therakos, Inc.
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Mr. Adolfo Ferreira
908-367-5455
Manufacturer Reason
for Recall		 There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.
FDA Determined
Cause 2		 Other
Action Therakos sent an "URGENT PRODUCT CORRECTION NOTIFICATION" dated September 1, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Additionally, a Confirmation of Receipt was attached to the letter for customers to complete and return. Contact Therakos Technical Support at 1-877-865-6850 for questions regarding this notice.
Quantity in Commerce 49 USA, 65 Foreign
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = LNR and Original Applicant = Mallinckrodt Pharmaceuticals Ireland Limited
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