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U.S. Department of Health and Human Services

Class 3 Device Recall AMT Feeding Set

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  Class 3 Device Recall AMT Feeding Set see related information
Date Initiated by Firm January 19, 2017
Date Posted February 17, 2017
Recall Status1 Terminated 3 on December 15, 2017
Recall Number Z-1224-2017
Recall Event ID 76264
510(K)Number K030784  K142971  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product AMT 12 inch Right Angle Feeding Set with Y-Port

Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Code Information Table 5: 8-1222  Box P/N - 8-1222 Box Lot Number - 161003-312  Box Exp. - 2019-09-01  Box UDI - (01)00842071108649(17)190901(10)161003-312  Pouch P/N - E8-1222 Pouch Lot Number - 160923-222  Pouch Exp. - 2016-09-01 Pouch UDI - (01)00842071107536(17)160901(10)160923-222 
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8000 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information Contact Customer Service
440-717-4000
Manufacturer Reason
for Recall		 Expired expiration dates are listed on the pouches.
FDA Determined
Cause 2		 Employee error
Action Applied Medical Technology Inc. sent an Urgent Medical Device Recall letter dated January 19, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Applied Medical Technology requests that customers IMMEDIATELY TAKE THE ACTION and return all devices in inventory subject to this recall. Do not use any device subject to this recall. Complete and return to Applied Medical Technology the enclosed RECALL NOTIFICATION. For further questions please call (440) 717- 4000.
Quantity in Commerce 110
Distribution US Distribution to the states of : AZ, CA, CO, CT, FL, GA, ID, LA, ME, MO, MN, NC, OH, OK, OR, TN, TX, UT, WA, and WI., and to the United Kingdom.
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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