AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102,...

FDA Device Recall #Z-0698-2021 — Class III — November 10, 2020

Recall Summary

Recall Number Z-0698-2021
Classification Class III — Low risk
Date Initiated November 10, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Applied Medical Technology Inc
Location Brecksville, OH
Product Type Devices
Quantity N/A

Product Description

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Reason for Recall

The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

Distribution Pattern

US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.

Lot / Code Information

Box Lot Number 200918-103; Pouch Lot Number 200902-075

Other Recalls from Applied Medical Technology Inc

Recall # Classification Product Date
Z-0498-2026 Class II Applied Medical Technology, Inc., NutraGlide, 6... Oct 6, 2025
Z-0494-2026 Class II Applied Medical Technology, Inc., NutraGlide, 5... Oct 6, 2025
Z-0495-2026 Class II Applied Medical Technology, Inc., NutraGlide, 5... Oct 6, 2025
Z-0497-2026 Class II Applied Medical Technology, Inc., NutraGlide, 6... Oct 6, 2025
Z-0496-2026 Class II Applied Medical Technology, Inc., NutraGlide, 5... Oct 6, 2025

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.