Device product
Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
Z-2107-2015
Product summary
- Firm
- Covidien LLC
- Event
- Event 71113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,630 units
- Official record key
device-enforcement:Z-2107-2015
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