Events

Recall of Device Recall Corflo AntiI.V. NG Tube

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

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
    48726
  • Event Risk Class
    Class 3
  • Event Number
    Z-2306-2008
  • Event Initiated Date
    2008-06-25
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72005
  • 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 - Product Code KNT
  • Reason
    The male luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.
  • Action
    Cardinal Health notified the accounts who ordered the affected feeding tubes via letter dated 6/25/08, informing them that the feeding tube may have the wrong male Luer adapter component, which can cause leakage around the tube outside of the body. Upon review of the letter, the accounts were requested to inspect their inventory and immediately destroy any affected product found and to telephone Cardinal Health/VIASYS MedSystems Technical Service at 1-800-323-6305 for arrange for credit. Dealers were requested to notify their customers. Any questions were directed to Cardinal Health/VIASYS MedSystems at 800-403-3400, ext. 3473. The accounts were also requested to complete and fax back the enclosed acknowledgement form indicating if they have any remaining inventory of the recalled scissors or not.

Device

Device Recall Corflo AntiI.V. NG Tube
  • Model / Serial
    catalog/reorder number 20-1225AIV, lot 32601
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Illinois, Kentucky and Missouri
  • Product Description
    Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090 || Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA