—#137903

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

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot number begins 508xxxx or lower

Why it was recalled

Devon Light Gloves contain splits or holes compromising the sterility

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

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.

Timeline

Recall initiated: 2015-04-16
Posted by FDA: 2015-07-20
Terminated: 2017-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.