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U.S. Department of Health and Human Services

Class 2 Device Recall AMT GJet LowProfile TransgastricJejunal Feeding Device

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  Class 2 Device Recall AMT GJet LowProfile TransgastricJejunal Feeding Device see related information
Date Initiated by Firm January 26, 2016
Create Date April 14, 2016
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-1497-2016
Recall Event ID 73339
510(K)Number K110804  K123716  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
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.
Code Information Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8000 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information Contact
440-717-4000
Manufacturer Reason
for Recall		 The firm received complaints that the product is shorter in length than indicated on the label.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 20 units
Distribution Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNT and Original Applicant = APPLIED MEDICAL TECHNOLOGY, INC.
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