RecallDepth

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.

Company
Applied Medical Technology Inc
Recall Initiated
January 26, 2016
Terminated
October 27, 2016
Recall Number
Z-1497-2016
Quantity
20 units
Firm Location
Brecksville, OH

Reason for Recall

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

Distribution

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

Lot / Code Info

Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09

Root Cause

Employee error

Action Taken

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.

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