Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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

FDA Recall Z-2250-2016 · Posted None

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.

↑