FDAFDA · Food and drugs·Recall number Z-2238-2024
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Published July 10, 2024 · Recall initiated: May 14, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices were labelled with the incorrect guidewire labelling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Applied Medical Technology Inc
- Distributor
- US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
- Lot
- Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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