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Terminated

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.

FDA Recall Z-1497-2016 · Posted None

Recalling FirmApplied Medical Technology Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2016-01-26
Date Terminated2016-10-27
Product Quantity20 units

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123716AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KITApplied Medical Technology, Inc. · 2013-04-19K110804AMT G-J TUBEApplied Medical Technology, Inc. · 2011-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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