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FDA Medical Device Recalls (openFDA)

Applied Medical Technology Inc: 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.

Recall number
Z-1497-2016
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.
Status
Terminated
Initiated
2016-01-26
Posted
not on file
Terminated
2016-10-27
Reason
The firm received complaints that the product is shorter in length than indicated on the label.
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
20 units
Distribution
Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
Lot, serial or model codes
Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09
510(k) numbers
["K110804","K123716"]
PMA numbers
not on file
Product code
KNT
Firm FEI
1526012
Firm city
Brecksville
Firm state
OH
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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