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