FDA Recall
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.
Recall: Z-1497-2016
·
Initiated January 26, 2016
Recall
- Recall Number
- Z-1497-2016
- Event Number
- 73339
- Firm
- Applied Medical Technology Inc
- FEI Number
- 1526012
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- January 26, 2016
- Terminated
- October 27, 2016
- Address
- 8000 Katherine Blvd, Brecksville, OH, 44141-4202
Description
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.
Reason
The firm received complaints that the product is shorter in length than indicated on the label.
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.
Distribution
Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
Quantity
20 units