Events

Recall of Device Recall V. Mueller

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
    53137
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2010
  • Event Initiated Date
    2009-08-28
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84750
  • 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
    Vertebral Biopsy set component - Product Code FCG
  • Reason
    The craig calibrated cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.
  • Action
    Cardinal Health sent Urgent Product Recall letters dated 8/28/09 to all customers who received the product during the recalled period on the same day via UPS Next Day Air. The accounts were informed of the problem with the cannula, and were instructed to functionally test the cannula by passing the toothed cutter within it to ensure the cutter advances freely into the cannula. If any restriction is noticed, the product should be segregated and returned to Cardinal Health. The accounts were requested to complete and return by fax the enclosed acknowledgement form, indicating the number of affected cannulas being returned. Any questions were directed to V. Mueller Customer Service at 800-323-9088.

Device

Device Recall V. Mueller
  • Model / Serial
    catalog #OS5000-005, lot number K08
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000
  • 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