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U.S. Department of Health and Human Services

Class 2 Device Recall Therakos Cellex Procedural Kits

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  Class 2 Device Recall Therakos Cellex Procedural Kits see related information
Date Initiated by Firm December 02, 2010
Date Posted July 19, 2011
Recall Status1 Terminated 3 on February 19, 2015
Recall Number Z-2839-2011
Recall Event ID 57518
PMA Number P860003 
Product Classification Extracorporeal Photopheresis System - Product Code LNR
Product Therakos Cellex Procedural Kits.

Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
Code Information Lot: Y302 Product code: CLXUSA
Recalling Firm/
Manufacturer		 Therakos Inc
1001 Us Highway 202
Raritan NJ 08869
For Additional Information Contact Jean O' Connor
908-218-8776
Manufacturer Reason
for Recall		 Cellex Procedural kits may have minor tears in their Tyvek covers.
FDA Determined
Cause 2		 Employee error
Action Therakos, Inc. sent an "Important Product Notification" dated December 2, 2010 to all affected customers. The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form. For additional information contact Therakos Customer Technical Services at 877-865-6850.
Quantity in Commerce 110 units
Distribution Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.
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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