FDA Enforcement
Class II
Completed
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Recall: Z-2238-2024
·
Reported July 10, 2024
Enforcement
- Recall Number
- Z-2238-2024
- Event ID
- 94702
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Applied Medical Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2024
- Initiation Date
- May 14, 2024
- Classification Date
- June 28, 2024
- Address
- 8006 Katherine Blvd, N/A, Brecksville, OH, 44141-4202, United States
Description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Reason
Devices were labelled with the incorrect guidewire labelling.
Code Info
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Distribution
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Quantity
74 units