Recall Z-2250-2016— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2015-04-29, terminated 2016-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-29
- Terminated
- 2016-11-03
- Firm location
- Williamston, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.