Events

Recall of Device Recall Vacora Plastic Radiolucent Coaxial

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

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
    52455
  • Event Risk Class
    Class 2
  • Event Number
    Z-1879-2009
  • Event Initiated Date
    2009-03-26
  • Event Date Posted
    2009-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83076
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Some vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
  • Action
    Bard Peripheral Vascular, Inc. issued an "Urgent Medical Device Recall Notification" dated March 27, 2009 informing Customers of the affected devices. The firm requested that all affected product be removed and returned along with returning a Recall and Effectiveness Check Form via fax. For further information, contact Bard Peripheral Vascular, Inc. at 1-800-321-4254.

Device

Device Recall Vacora Plastic Radiolucent Coaxial
  • Model / Serial
    Lot Numbers: HUSA1667, HUSA1668, HUSA1669, HUSA1670, HUSA1671, HUSC1173, HUSC1174, HUSC1175, HUSC1176, HUSC1527, HUSC1528, HUSC1529, HUSC1530, HUSC1531, HUSC1532. HUSC1533, HUSC1535, HUSC1536, HUSC1537, HUSC1072, HUSC1078, HUSC1859, HUSC1074, HUSC1074, HUSC1075, HUSC1076, HUSC1077, HUSD2650, HUSD2651, HUSD2652, HUSD2653, HUSD2654, HUSD2655, HUSD2656, HUSG0389, HUSG0390, HUSG0391, HUSG0591, HUSG0592, HUSG0593, HUSG0594, HUSG0595, HUSG0596, HUSI1060, HUSI1061, HUSI1062, HUSI1063, HUSI1064, HUSJ0192, HUSJ0193, HUSJ0194, HUSJ 0195 and HUSJ0196.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P).
  • Manufacturer
    Bard Peripheral Vas

Manufacturer

Bard Peripheral Vas
  • Manufacturer Address
    Bard Peripheral Vas, 1415 W 3rd St Ste 109, Tempe AZ 85281-7634
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA