Medical device recalls Moderate risk

Centurion Medical Products Corporation recalls Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOS…

Recall date
April 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2250-2016
FDA classification
Class II
Brand / firm
Centurion Medical Products Corporation
Sold / distributed
KS, IN, IA, KY, MT, SD

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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