AMT Initial Placement Dilator Set. Used to place recall: Labeling Error
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Why was AMT Initial Placement Dilator Set. Used to place recalled?
Devices were labelled with the incorrect guidewire labelling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
- Product
- AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
- Recalling firm
- Applied Medical Technology Inc
- Quantity
- 74 units
- Distribution
- US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)