FDA-Device2015-07-29Class II
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
Covidien LLC
Hazard
Devon Light Gloves contain splits or holes compromising the sterility
Sold states
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.
Affected count
77,588 kits
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2015Don't want to check this manually?
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