Events

Recall of Device Recall Bone Marrow Biopsy 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
    50156
  • Event Risk Class
    Class 2
  • Event Number
    Z-0451-2009
  • Event Initiated Date
    2008-07-16
  • Event Date Posted
    2009-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74873
  • 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 KNW
  • Reason
    Product packaging for bone biopsy trays/blisters may have a hole in the formed tray.
  • Action
    Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance.

Device

Device Recall Bone Marrow Biopsy Needle
  • Model / Serial
    Lot Number 81371NGF and 81081MRM.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
  • Product Description
    Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Manufacturer Address
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Manufacturer Parent Company (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA