AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

FDA Recall #Z-2238-2024 — Class II — May 14, 2024

Recall #Z-2238-2024 Date: May 14, 2024 Classification: Class II Status: Ongoing

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.

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