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AMT Bridle recallZ-1223-2017 · Applied Medical Technology Inc · initiated Jan 19, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Applied Medical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Expired expiration dates are listed on the pouches.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1223-2017
Status
Terminated
Initiated by the company
Jan 19, 2017
Posted by the FDA
Feb 17, 2017
Recalling firm
Applied Medical Technology Inc
Quantity
110
Product code
KNT
FDA submissions
K030784, K142971
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K030784, K142971 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 76264).

Sources and updates

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