Events

Recall of Device Recall Bard TruGuide Disposable Coaxial Biopsy Needle

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
    74663
  • Event Risk Class
    Class 2
  • Event Number
    Z-2547-2016
  • Event Initiated Date
    2016-07-06
  • Event Date Posted
    2016-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148135
  • 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
    Biopsy needle - Product Code FCG
  • Reason
    May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
  • Action
    Bard Peripheral Vascular (BVP) sent an Urgent Medical Device Recall Notification letter dated July 6, 2016 to all affected customers via FedEx with proof of delivery notification.. The letter identified the product, the problem, and the action to be taken by the customer. The notification provided customers the following instructions: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within your institution for affected product code I lot number combination listed in the recall notice. If you have further distributed any of the product code I lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from shelves. 4. If used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by recall has been removed from inventory; 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product in stock even if no longer have possession of the recalled product. 6. Call the firm's Recall Coordinator Raye Seisinger at 1-800-321-4254 Option #2 Ext 2501 (M-F 6am to 3pm MST) or email at raye.seisinger@crbard.com. Once all information has been verified, the Recall Coordinator will issue a Return Authorization (XC) Number or Consignment Recall Number (XH) to facilitate the expedient return of the product. BPV will provide a credit for your returned product. 7. Fax the Recall and Effectiveness Check Form to BPV at 1-800-994-6772. If cannot FAX the form, please call the BPV recall coordinator at 1-800-321-4254 Option #2 Ext 2501) and report the required information verbally. 8. A mailing label is enclosed to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and i

Device

Device Recall Bard TruGuide Disposable Coaxial Biopsy Needle
  • Model / Serial
    Lot Number: REZK0479
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
  • Product Description
    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product || Part Number C1816B || The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
  • 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