Events

Recall of MediVac NonConductive Suction 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
    56563
  • Event Risk Class
    Class 2
  • Event Number
    Z-2454-2010
  • Event Initiated Date
    2010-08-16
  • Event Date Posted
    2010-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93975
  • 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
    Tubing, noninvasive - Product Code GAZ
  • Reason
    The packaging seals may not be intact, resulting in compromised sterility for the listed medi-vac non-conductive tubing.
  • Action
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated August 16, 2010 to consignees, identifying the reason for the recall, the affected lots, and actions to be taken. Cardinal has inspected all packages in their warehouses and removed the affected products. All packages that have been inspected have a 3/4" green dot on the front of each unit and on the case carton label. " Cardinal Health end users were instructed to segregate and destroy their affected product and request credit or replacement " Distributor customers were instructed to destroy their product and request credit or replacement " Distributors were instructed to conduct sub-recalls and return their inventory to Cardinal Health " To arrange for credit or replacement of the product destroyed, the accounts were instructed to call customer service at 800-964-5227 or 888-444-5440. " All customers were requested to complete the enclosed Recall Acknowledgment Form acknowledging receipt of the letter and the number of tubing units destroyed, and fax it to 847-689-9101. Cardinal Health can be contacted at 800-292-9332. Cardinal sent recall letters dated 8/26/10 to their PreSource kit/module customers via UPS next day air, informing them that the Medi-Vac Non-conductive Suction Tubing listed may have packaging seals that are compromised. The accounts were informed that Cardinal has inspected tubing packages in their warehouses and removed the affected products. All packages that have been inspected will have a 3/4" green dot on the front of each package. Enclosed with the recall letter were recall labels to affix to each affected Presource pack/module in the account's inventory. These labels instruct the user NOT to use the affected tubing component and to remove and discard the component upon opening the kit. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of packs/modules on hand. Distributo

Device

MediVac NonConductive Suction Tube
  • Model / Serial
    All lots prior to Y10Kxxxx
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including USA.
  • Product Description
    Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mexico; catalog N712 and NEX712 (European label)
  • 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