Z-2238-2024 Class II
FDA device recall Z-2238-2024 was initiated by Applied Medical Technology Inc on May 14, 2024 and is designated Class II. Reason for recall: Devices were labelled with the incorrect guidewire labelling. Affected quantity: 74 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2024
- Initiation Date
- May 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Reason for Recall
Devices were labelled with the incorrect guidewire labelling.
Distribution Pattern
US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Code Information
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.