Events

Recall of Device Recall AMT Feeding Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Technology Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76264
  • Event Risk Class
    Class 3
  • Event Number
    Z-1224-2017
  • Event Initiated Date
    2017-01-19
  • Event Date Posted
    2017-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152952
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    Expired expiration dates are listed on the pouches.
  • 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.

Device

Device Recall AMT Feeding Set
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 12 inch Right Angle Feeding Set with Y-Port || Used with Nasogastric/Nasointestinal (NG/NI) tubes.
  • Manufacturer
    Applied Medical Technology Inc

Manufacturer

Applied Medical Technology Inc
  • Manufacturer Address
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • Manufacturer Parent Company (2017)
    Applied Medical Technology Inc.
  • Source
    USFDA