Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
FDA Recall Z-2106-2015 · Posted 2015-07-20
Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFSY
Date Initiated2015-04-16
Date Terminated2017-06-28
Product Quantity26,108,946 units
Reason for Recall
Devon Light Gloves contain splits or holes compromising the sterility
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.