Events

Recall of Device Recall Hawkins III (BLN) Breast Localization Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Device Technologies, 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
    48623
  • Event Risk Class
    Class 2
  • Event Number
    Z-1878-2008
  • Event Initiated Date
    2008-05-06
  • Event Date Posted
    2008-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71739
  • 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
    Needle - Product Code GAA
  • Reason
    The sterility of the product cannot be guaranteed.
  • Action
    The firm sent a letter to its consignees on 5/6/08, informing of the recall and requesting that they complete and return by fax the attached customer acknowledgement form. For assistance, contact Medical Device Technologies, Inc., dba Angiotech at 1-352-338-0440 ext. 350 or ext. 353.

Device

Device Recall Hawkins III (BLN) Breast Localization Needle
  • Model / Serial
    Lot #; 80281L5V
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to Mexico.
  • Product Description
    Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Manufacturer Address
    Medical Device Technologies, Inc., 3600 SW 47th Ave, Gainesville FL 32608-7555
  • Source
    USFDA