AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA Recall #Z-2238-2024 — Class II — May 14, 2024
Product Description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Reason for Recall
Devices were labelled with the incorrect guidewire labelling.
Recalling Firm
Applied Medical Technology Inc — Brecksville, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
74 units
Distribution
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Code Information
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.