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Terminated

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

FDA Recall Z-2108-2015 · Posted 2015-07-20

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFSY
Date Initiated2015-04-16
Date Terminated2017-06-28
Product Quantity559,108 kits

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.

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