Recall Z-1497-2016— Applied Medical Technology Inc

Name: FDA recall Z-1497-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-26

Class II · Terminated

Class II FDA medical device recall by Applied Medical Technology Inc, initiated 2016-01-26, terminated 2016-10-27. It names 2 FDA 510(k) clearances: K123716, K110804. Product: AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.. Reason: The firm received complaints that the product is shorter in length than indicated on the label..

Recalling firm: Applied Medical Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-26
Terminated: 2016-10-27
Firm location: Brecksville, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K123716 — AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KITApplied Medical Technology, Inc.·cleared 2013-04-19
K110804 — AMT G-J TUBEApplied Medical Technology, Inc.·cleared 2011-10-19

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 G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.

Reason for recall

The firm received complaints that the product is shorter in length than indicated on the label.

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