Recall Z-2238-2024— Applied Medical Technology Inc

Name: FDA recall Z-2238-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-14

Class II · Ongoing

Class II FDA medical device recall by Applied Medical Technology Inc, initiated 2024-05-14. It names one FDA 510(k) clearance: K073034. Product: AMT Initial Placement Dilator Set. Used to place gastrostomy devices.. Reason: Devices were labelled with the incorrect guidewire labelling..

Recalling firm: Applied Medical Technology Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-14
Firm location: Brecksville, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K073034 — AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)Applied Medical Technology, Inc.·cleared 2008-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

Reason for recall

Devices were labelled with the incorrect guidewire labelling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.