FDA-Device2016-07-27Class II

Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY

Centurion Medical Products Corporation
Hazard

Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound.

Sold states
KS, IN, IA, KY, MT, SD
Affected count
483
Manufactured in
100 Centurion Way, N/A, Williamston, MI, United States
Products
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2250-2016

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