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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-2110-2015
Recall Event ID 71113
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove
Catalog Numbers/Description:
31144895 7614-T4 Single Basin Set Up Kit
31144960 7693-T4 Single Basin Set Up Kit
31144978 7766 Double Basin Set Up Kit
31145215 7896 Double Basin Set Up Kit
31145231 7897 Double Basin Set Up Kit
31145249 7897-T8 Double Basin Set Up Kit
31145298 7896-T8 Double Basin Set Up Kit
31145496 7696-T4 Single Basin Set Up Kit
31145520 7614 Single Basin Set Up Kit
31145546 7693 Single Basin Set Up Kit
31145629 7696 Single Basin Set Up Kit
31153938 7756-KST Surgical Set Up Kit
31154266 7656-KST Surgical Set Up Kit
31321097 7697 Surgical Set Up Kit
31324299 7830-HOH Surgical Set Up Kit
31451092 7600-DNV Surgical Set Up Kit
31453098 7682-MHP Surgical Set Up 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 33,256 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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