Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreski...

FDA Device Recall #Z-0120-2020 — Class II — August 28, 2019

Recall Summary

Recall Number Z-0120-2020
Classification Class II — Moderate risk
Date Initiated August 28, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity 1530 each

Product Description

Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

Reason for Recall

A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.

Distribution Pattern

Nationwide

Lot / Code Information

Batch/Lot: 2019061801

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.