Events

Recall of UltraClip Dual Trigger breast tissue marker

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

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
    65046
  • Event Risk Class
    Class 2
  • Event Number
    Z-1524-2013
  • Event Initiated Date
    2013-04-16
  • Event Date Posted
    2013-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117792
  • 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
    Clip, implantable - Product Code FZP
  • Reason
    Bard peripheral vascular (bpv) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.
  • Action
    Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.

Device

UltraClip Dual Trigger breast tissue marker
  • Model / Serial
    Affected Product Lots with the following Product Code and Lot Number combinations.   Product Code  864017D  864017D  864017D  864017D  864017D  864017D  864017D  864017DL   Lot Number   HUWI1522   HUWI1941   HUWI1942   HUWI1943   HUWJ1851   HUWJ1852   HUWK0350   HUWJ1610
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA Nationwide and Internationally to Europe.
  • Product Description
    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. || Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA