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Recall Observatory FDA recall evidence

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

April 16, 2015

Class II

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

    reason.no_named_rule · v1.0.0

    Devon Light Gloves contain splits or holes compromising the sterility