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Recall Observatory FDA recall evidence

Device 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.

Z-1497-2016

January 26, 2016

Class II

Product summary

Firm
Applied Medical Technology Inc
Event
Event 73339
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1497-2016

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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