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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm April 16, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on June 28, 2017
Recall Number Z-2112-2015
Recall Event ID 71113
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Surgical Kit Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
573326 7497-HLS Surgical Kit
573328 7437-NRF SURGICAL ASC KIT
573343 7499-88 SURGICAL KIT with Light Gloves
573346 7499-TLG Surgical Kit with Edge
573359 7499-HLW Surgical KIT
573368 7494-CAB2 SURGICAL KIT
573776 7520-BHP SURGICAL KIT
573777 7527-BHB SURGICAL KITS
573798 7496-8KB Surgical KIT
31144507 7519 Minor Surgical Kit
31175089 7497-8T6 Surgical Kit
31321097 7697 Surgical Set Up Kit
31451480 7493-SFW SURGICAL KIT
31460432 7596-SHH Surgical KIT
50000947 7413-CAD Surgical KIT
50001029 7417-PCP Surgical KIT
50001052 7427-CFS Surgical KIT
Code Information Lot number begins 508xxxx or lower
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Catherine Wrenn
203-492-5415
Manufacturer Reason
for Recall		 Devon Light Gloves contain splits or holes compromising the sterility
FDA Determined
Cause 2		 Process control
Action Medtronic/Covidien initiated recall on April 16, 2015 via FedEx and certified mail Customers were instructed to discontinue use of the product and return all inventory and kits to Medtronic (Covidien) -Attention: Devon" Light Glove 110 Kendall Park Lane. Atlanta, GA 30336. If you have any questions contact your Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am to 6:30pm ET, at (800) 882-5878.
Quantity in Commerce 114,813 kits
Distribution Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.
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.
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