FDA Medical Device Recalls (openFDA)
Applied Medical Technology Inc: AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Recall number
- Z-1223-2017
- Recalling firm
- Applied Medical Technology Inc
- Product
- AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Status
- Terminated
- Initiated
- 2017-01-19
- Posted
- 2017-02-17
- Terminated
- 2017-12-15
- Reason
- Expired expiration dates are listed on the pouches.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K030784","K142971"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1526012
- Firm city
- Brecksville
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28