PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 27, 2016 Initiated: April 29, 2015 #Z-2250-2016

Product Description

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

Reason for Recall

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.

Details

Units Affected
483
Distribution
KS, IN, IA, KY, MT, SD
Location
Williamston, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Centurion Medical Products Corporation. Units affected: 483.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2250-2016.