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FDA Medical Device Recalls (openFDA)

Applied Medical Technology Inc: AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Recall number
Z-1224-2017
Recalling firm
Applied Medical Technology Inc
Product
AMT 12 inch Right Angle Feeding Set with Y-Port 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 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
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

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