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Recall Observatory FDA recall evidence

Device product

Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin Kit

Z-2115-2015

April 16, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 71113
Status
Terminated
Classification
Class II
Quantity
77,588 kits
Official record key
device-enforcement:Z-2115-2015

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