Z-1223-2017Class III

AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes

Name: Z-1223-2017 AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes
Creator: Applied Medical Technology Inc
Published: 2017-01-19
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2017-01-19 / Terminated / root cause: manufacturing process

FDA source

Applied Medical Technology Inc began a recall of AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes on 2017-01-19. FDA classified it as Class III and gives the reason as "Expired expiration dates are listed on the pouches". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1223-2017
Classification: Class III
Status: Terminated
Initiated: 2017-01-19
Posted: 2017-02-17
Terminated: 2017-12-15
Recalling firm: Applied Medical Technology Inc
Product: AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Expired expiration dates are listed on the pouches.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1223-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-17
Z-1224-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-17

Product code KNT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)