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
FDA Recall Z-2250-2016 · Posted None
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeFSY
Date Initiated2015-04-29
Date Terminated2016-11-03
Product Quantity483
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.
Firm Action
On 4/28/2015, URGENT PRODUCT RECALL NOTICE notifications were sent to the affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Root Cause
Nonconforming Material/Component
Distribution Pattern
KS, IN, IA, KY, MT, SD
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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