FDA recall Z-2238-2024

Applied Medical Technology Inc · Class II · device

Product

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

Reason for recall

Devices were labelled with the incorrect guidewire labelling.

Distribution

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

Key facts

Status
Completed
Initiation date
2024-05-14
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brecksville, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2024