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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic 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-2108-2015
Recall Event ID 71113
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Mini-Kits, Sterile-Kits containing the Devon Light Glove

Catalog Numbers/Description
31141479 K-1842-S OR Mini Kit
31141487 K-1560-S3 OR Mini Kit
31141495 K-1530-S3 OR Mini Kit
31141537 K-1940-S OR Mini Kit
31141552 K-1920-S OR Mini Kit
31141560 K-1200-S3 OR Mini Kit
31141578 K-1840-S OR Mini Kit
31141586 K-1660-S OR Mini Kit
31141602 K-1630-S OR Mini Kit
31141610 K-1615-S OR Mini Kit
31141628 K-1614-S OR Mini Kit
31141651 K-1560-S OR Mini Kit
31141669 K-1530-S OR Mini Kit
31141677 K-1200-S OR Mini Kit
31141784 K-1960-S OR Mini Kit
31141859 K-1615-S3 OR Mini Kit
31141875 K-1940-S3 OR Mini Kit
31145025 7496-8 MINI-PLUS KIT
31145397 7497-8 MINI-PLUS KIT
31145413 7497-88 Mini-Plus Kit
31150470 7496-PUP MINI PLUS KIT
50000148 K-1920-COE MINI-KIT
50047403 7496-HCS MINI-PLUS KIT
50047405 7496-HES MINI-PLUS KIT
573375A MINI-PLUS 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 559,108 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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