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U.S. Department of Health and Human Services

Class 2 Device Recall Therakos UVAR XTS Procedural Kits

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  Class 2 Device Recall Therakos UVAR XTS Procedural Kits see related information
Date Initiated by Firm February 01, 2011
Date Posted April 28, 2011
Recall Status1 Terminated 3 on March 13, 2014
Recall Number Z-2067-2011
Recall Event ID 57912
PMA Number P860003 
Product Classification Extracorporeal Photopheresis System - Product Code LNR
Product Therakos UVAR XTS Procedural Kits

Is indicated for use in the ultraviolet-A (UVA) irradiation.
Code Information Lots Y703 through Y707 and Y709 though Y726  Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015. 
Recalling Firm/
Manufacturer		 Therakos Inc
1001 Us Highway 202
Raritan NJ 08869
For Additional Information Contact Mr. Adolfo Ferreira
908-367-5455
Manufacturer Reason
for Recall		 Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
FDA Determined
Cause 2		 Process control
Action Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.
Quantity in Commerce 4,323 kits
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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