Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VA...

FDA Device Recall #Z-2250-2016 — Class II — April 29, 2015

Recall Summary

Recall Number Z-2250-2016
Classification Class II — Moderate risk
Date Initiated April 29, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity 483

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.

Distribution Pattern

KS, IN, IA, KY, MT, SD

Lot / Code Information

Code Lot # Description exp date SUT18365 2012070350 ED SUTURE KIT Sep-14 MNS6710 2012070990 VAGINAL DELIVERY TRAY Jan-15 MNS6710 2012082090 VAGINAL DELIVERY TRAY Feb-15 MNS6710 2012092490 VAGINAL DELIVERY TRAY Apr-15 MNS6710 2012120390 VAGINAL DELIVERY TRAY Apr-15 MNS4635 2012081390 ENDOSCOPY TRAY Feb-15 OR1640 2012040990 MINOR BASIN SET Jan-15 OR1640 2012123190 MINOR BASIN SET Apr-15 OR1575 2012071690 LAPAROSCOPIC BASIN TRAY Nov-14 OR1575 2012091090 LAPAROSCOPIC BASIN TRAY Feb-15 OR1575 2013010490 LAPAROSCOPIC BASIN TRAY Apr-15

Other Recalls from Centurion Medical Products Corporation

Recall # Classification Product Date
Z-1047-2020 Class II Centurion- Dressing Change Tray DT10290S CENTR... Dec 11, 2019
Z-1091-2020 Class II Centurion- ENT SNUF3 SNUFFER KIT Y Dec 11, 2019
Z-1063-2020 Class II Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... Dec 11, 2019
Z-1090-2020 Class II Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... Dec 11, 2019
Z-1058-2020 Class II Centurion- Umbilical Trays UVT1045 UMBILICAL A... Dec 11, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.