FDA-Device2024-07-10Class II
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Applied Medical Technology Inc
Hazard
Devices were labelled with the incorrect guidewire labelling.
Sold states
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Affected count
74 units
Manufactured in
8006 Katherine Blvd, N/A, Brecksville, OH, United States
Products
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2024Don't want to check this manually?
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