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U.S. Department of Health and Human Services

Class 3 Device Recall AMT Bridle Nasal Tube Retaining System

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 Class 3 Device Recall AMT Bridle Nasal Tube Retaining Systemsee related information
Date Initiated by FirmJanuary 19, 2017
Date PostedFebruary 17, 2017
Recall Status1 Terminated 3 on December 15, 2017
Recall NumberZ-1223-2017
Recall Event ID 76264
510(K)NumberK030784 K142971 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductAMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Code Information Table 1: 4-4108M  Box P/N - 4-4108M  Box Lot Number - 161018-193  Box Exp. - 2019-09-01 Box UDI - (01)00842071106638(17)190901(10)161018-193  Pouch P/N - E4-4108M  Pouch Lot Number - 160930-186  Pouch Exp. - 2010-09-01  Pouch UDI - (01)00842071103934(17)100901(10)160930-186   Table 2: 4-4110  Box P/N - 4-4110  Box Lot Number - 161014-166 Box Exp. - 2019-10-01 Box UDI - (01)00842071106645(17)191001(10)161014-166  Pouch P/N - E4-4110 Pouch Lot Number - 161010-090  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103941(17)101001(10)161010-090   Table 3: 4-4114 Box P/N - 4-4114  Box Lot Number - 161021-139  Box Exp. - 2019-09-01 Box UDI - (01)00842071106669(17)190901(10)161021-139  Pouch P/N - E4-4114 Pouch Lot Number - 160926-242  Pouch Exp. - 2010-09-01 Pouch UDI - (01)00842071103965(17)100901(10)160926-242   Table 4: 4-4116 Box P/N - 4-4116 Box Lot Number - 161019-105  Box Exp. - 2019-09-01 Box UDI - (01)00842071106676(17)190901(10)161019-105  Pouch P/N - E4-4116  Pouch Lot Number - 161007-038  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103972(17)101001(10)161007-038   
FEI Number 1526012
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8000 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information ContactCustomer Service
440-717-4000
Manufacturer Reason
for Recall		Expired expiration dates are listed on the pouches.
FDA Determined
Cause 2		Employee error
ActionApplied 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 Commerce110
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = KNT
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