Events

Recall of Device Recall The EnCor biopsy probe

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
    60347
  • Event Risk Class
    Class 2
  • Event Number
    Z-0351-2012
  • Event Initiated Date
    2011-11-03
  • Event Date Posted
    2011-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105125
  • 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
    Instrument, biopsy, suction - Product Code FCK
  • Reason
    This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked encor (trademark) packaging trays, plastic petg tray the probe is packaged in was cracked.
  • Action
    The firm sent the customer notification letter on 11/07/11, via FedEx with proof of delivery notice. The letter notified customers of the reason for recall that units from the affected lot may have packaging damage resulting from transportation. The letter instructed customers to check all inventory locations , remove any identified product, to not use the affected product, and return the affected product to Bard Peripheral Vascular, Inc., 1415 W. 3rd Street, Tempe, Arizona 85281. The letter also instructed customers to fill out the recall and effectiveness check form and fax it to 1-800-894-6772. Customers were instructed to call 1-800-321-4254, Option #2 Ext 2727 for a return authorization number to facilitate the expedient return of the product. For questions regarding this recall call 480-894-9515

Device

Device Recall The EnCor biopsy probe
  • Model / Serial
    ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia
  • Product Description
    The EnCor¿ biopsy probe, designed for use with EnCor¿ and EnCor¿ Enspire Vacuum Assisted Biopsy (VAB) driver systems. || The EnCor¿ Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

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