Device product
Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
Z-2109-2015
Product summary
- Firm
- Covidien LLC
- Event
- Event 71113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81,252 kits
- Official record key
device-enforcement:Z-2109-2015
Official wording
Reason: Devon Light Gloves contain splits or holes compromising the sterility
Code information: Lot number begins 508xxxx or lower
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.
Derived failure modes
-
Unknown
Devon Light Gloves contain splits or holes compromising the sterility