Class II
Medical Device Recall: AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Applied Medical Technology Inc · May 14, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
74 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2238-2024
Status: ongoing
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