Events

Recall of Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Corpak Med Systems.

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
    61036
  • Event Risk Class
    Class 2
  • Event Number
    Z-1080-2012
  • Event Initiated Date
    2012-01-26
  • Event Date Posted
    2012-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107147
  • 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
    The wrong size twoomey adapter was packaged with the jejunal tube.
  • Action
    Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.

Device

Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor
  • Model / Serial
    catalog/reorder #30-7361, lot 46121, expiration: 2016-10
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.
  • Product Description
    CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition || Product Usage: For delivery of enteral nutrition
  • Manufacturer
    Corpak Med Systems

Manufacturer

Corpak Med Systems
  • Manufacturer Address
    Corpak Med Systems, 1001 Asbury Dr, Buffalo Grove IL 60089
  • Manufacturer Parent Company (2017)
    Halyard Health Inc
  • Source
    USFDA