ClearanceBrief
Recall Z-1497-2016 ยท KNT Tubes, Gastrointestinal (And Accessories)

Applied Medical Technology Inc

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.

DateJan 26, 2016
StatusTerminated
ReasonThe firm received complaints that the product is shorter in length than indicated on the label.
Root causeEmployee error
ActionOn 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.
Quantity20 units
DistributionDistributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K110804AMT G-J TUBE
Applied Medical Technology, Inc., Oct 19, 2011
K123716AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
Applied Medical Technology, Inc., Apr 19, 2013