Drug recall
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA recall event 94702 · Class II · Applied Medical Technology Inc
Key facts
| Event ID | 94702 |
|---|---|
| Recall numbers | Z-2238-2024 |
| Recalling firm | Applied Medical Technology Inc |
| Product type | Devices |
| Products | AMT Initial Placement Dilator Set. Used to place gastrostomy devices. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Devices were labelled with the incorrect guidewire labelling. |
| Initiation date | May 14, 2024 |
| Report date | Jul 10, 2024 |
| City | Brecksville |
| State | OH |
| Country | United States |
| FEI number | 1526012 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: