Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgica...

FDA Device Recall #Z-1663-2023 — Class II — April 28, 2023

Recall Summary

Recall Number Z-1663-2023
Classification Class II — Moderate risk
Date Initiated April 28, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TELEFLEX LLC
Location Morrisville, NC
Product Type Devices
Quantity 146,606 units

Product Description

Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation

Reason for Recall

Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the cartridge, the clip is mounted in a more variable position, allowing the clips to load farther back in the clip applier jaw grooves. This may potentially result in inappropriate or inadequate clip application to vascular structures.

Distribution Pattern

worldwide

Lot / Code Information

UDI/DI 24026704696394, Lot Numbers: 73A2200857, 73A2300018, 73A2300176, 73A2300326, 73A2300520, 73A2300778, 73D2200216, 73D2200559, 73E2200634, 73E2200874, 73E2201099, 73F2200193, 73F2200200, 73F2200482, 73F2200711, 73G2200168, 73G2200345, 73G2200560, 73G2200754, 73H2200115, 73H2200294, 73H2200433, 73H2200453, 73J2200747, 73J2200763, 73K2200014, 73K2200095, 73K2200101, 73K2200299, 73K2200566, 73K2200713, 73L2200064, 73L2200066

Other Recalls from TELEFLEX LLC

Recall # Classification Product Date
Z-1834-2023 Class I Slick Set Cuffed Endotracheal Tube and Stylet S... May 25, 2023
Z-1875-2023 Class I Endotracheal Tube oral/nasal uncuffed/plain - M... May 25, 2023
Z-1937-2023 Class I Endotracheal Tube oral/nasal uncuffed/plain - M... May 25, 2023
Z-1889-2023 Class I Endotracheal Tube oral/nasal Murphy Eye, High V... May 25, 2023
Z-1905-2023 Class I Slick Set Uncuffed Endotracheal Tube and Stylet... May 25, 2023

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.