Z-1497-2016Class II

AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For...

Name: Z-1497-2016 AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For...
Creator: Applied Medical Technology Inc
Published: 2016-01-26
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2016-01-26 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Technology Inc began a recall of 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... on 2016-01-26. FDA classified it as Class II and gives the reason as "The firm received complaints that the product is shorter in length than indicated on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1497-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-26
Posted: 2016-04-14
Terminated: 2016-10-27
Recalling firm: Applied Medical Technology Inc
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The firm received complaints that the product is shorter in length than indicated on the label.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 1/26/2016 the firm telephoned their customers notifying them of the recall. On 2/19/2016 the firm sent recall notification letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.
Quantity in commerce: 20 units
Distribution: Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
Product codes and lots: Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code KNT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)