Events

Recall of Device Recall ENFit(R) AMERITUS NG FEEDING TUBE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kentec Medical 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
    77729
  • Event Risk Class
    Class 2
  • Event Number
    Z-3074-2017
  • Event Initiated Date
    2017-06-23
  • Event Date Posted
    2017-07-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157812
  • 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
    Tube, feeding - Product Code FPD
  • Reason
    Inadequate detectability of radiopaque stripes.
  • Action
    The firm notified their consignees by telephone and email on 06/23/2017, and followed with a letter sent certified mail, on 07/07/2017. The letter instructed the consignee to cease use of the product, isolate it, and contact Kentec.

Device

Device Recall ENFit(R) AMERITUS NG FEEDING TUBE
  • Model / Serial
    a) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX, VA, IL, CA, KS
  • Product Description
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: || a) ENF-Y50P-40 || b) ENF-Y50P-50 || c) ENF-Y60P-40 || d) ENF-Y60P-50 || e) ENF-Y60P-90 || f) ENF-Y80P-40 || g) ENF-Y80P-50 || h) ENF-Y80P-80 || i) ENF-Y80P-90 || For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
  • Manufacturer
    Kentec Medical Inc

Manufacturer

Kentec Medical Inc
  • Manufacturer Address
    Kentec Medical Inc, 17871 Fitch, Irvine CA 92614-6001
  • Manufacturer Parent Company (2017)
    Kentec Medical Inc
  • Source
    USFDA