Events

Recall of Device Recall CORFLO, PEG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CORPAK MedSystems, 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
    76465
  • Event Risk Class
    Class 2
  • Event Number
    Z-2161-2017
  • Event Initiated Date
    2017-02-03
  • 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=153276
  • 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
    Firm is initiating voluntary correction of corflo peg with enfit. barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
  • Action
    Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.

Device

Device Recall CORFLO, PEG
  • Model / Serial
    Catalogue Numbers: 50-6112
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
  • Product Description
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); || Product Usage: || CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
  • Manufacturer
    CORPAK MedSystems, Inc.

Manufacturer

CORPAK MedSystems, Inc.
  • Manufacturer Address
    CORPAK MedSystems, Inc., 1001 Asbury Dr, Buffalo Grove IL 60089-4528
  • Manufacturer Parent Company (2017)
    Halyard Health Inc
  • Source
    USFDA