Events

Recall of Device Recall Mick TP Prostate Seeding Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mick Radio Nuclear Instr 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
    32046
  • Event Risk Class
    Class 3
  • Event Number
    Z-0857-05
  • Event Initiated Date
    2005-03-30
  • Event Date Posted
    2005-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39007
  • 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, Isotope, Gold, Titanium, Platinum - Product Code IWF
  • Reason
    Some of the mick tp prostate seeding needles do not fit properly into the mick 200-tpv applicator. firm received one complaint during use of the mick 200 tpv applicator.
  • Action
    Recall Notices (dated 3/30/05) were sent to the consignees by First Class Mail on 3/30/05. Follow-up phone calls to the consignees were initiated on 4/22/05. Recall was expanded for 7 additional lots, and recall notices (dated 8/09/05) were sent to the direct consignees (medical facilities).

Device

Device Recall Mick TP Prostate Seeding Needle
  • Model / Serial
    Lots: M121504-07 (Exp. 12/15/09), M012605-01 (Exp. 1/26/10), M012805-01 (Exp. 1/28/10); --- 8/09/05 RECALL EXPANSION (7 Lots): M110204-01 (Exp. 11/02/09), M110204-04 (Exp. 11/02/09), M110504-02 (Exp. 11/05/09), M120804-01 (Exp. 12/08/09), M120904-01 (Exp. 12/09/09), M121004-03 (Exp. 12/10/09), M121404-01 (Exp. 12/14/09)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
  • Product Description
    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
  • Manufacturer
    Mick Radio Nuclear Instr Inc

Manufacturer

Mick Radio Nuclear Instr Inc
  • Manufacturer Address
    Mick Radio Nuclear Instr Inc, 521 Homestead Avenue, Mount Vernon NY 10550-4619
  • Source
    USFDA