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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-2111-2015
Recall Event ID 71113
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove

Catalog Numbers/Decription:
573328 7437-NRF SURGICAL ASC KIT
50000511 7516-UNI Universal ASC Kit
50000512 7557-UNI Universal ASC Kit
50000515 7667-BRT Breast ASC 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 4,136 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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