AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Summary
The FDA issued a Class II for AMT Initial Placement Dilator Set. Used to place gastrostomy devices. by Applied Medical Technology Inc. Reason: Devices were labelled with the incorrect guidewire labelling..
Details
Source
Device Recall
External ID
Z-2238-2024
Action Date
2024-07-10
Status
Completed
Category
device
Product Description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Lot/Code Info: Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Quantity Affected: 74 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-14
Company
Brecksville, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Applied Medical Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Applied Medical Technology Inc have FDA actions?
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2238-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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