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Recall Observatory FDA recall evidence

Device product

Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE

Z-2106-2015

April 16, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71113
Status
Terminated
Classification
Class II
Quantity
26,108,946 units
Official record key
device-enforcement:Z-2106-2015

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