• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Rectal Retractor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Rectal Retractor
see related information
Date Posted January 31, 2013
Recall Status1 Terminated on April 10, 2014
Recall Number Z-0759-2013
Recall Event ID 61879
Premarket Notification
510(K) Number
K011657 
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
Product Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code Information All lots
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville, Virginia 22903-4584
For Additional Information Contact Pete Coronado
434-977-8495
Manufacturer Reason
for Recall
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Action Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory.
Quantity in Commerce 344 pieces
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = MICK RADIO-NUCLEAR INSTRUMENTS, INC.
-
-