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

Reason: Devices were labelled with the incorrect guidewire labelling.

Code information: Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.

Distribution pattern: US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.