Events

Recall of Device Recall Blue Torch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blue Torch Medical Technologies.

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
    27068
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-03
  • Event Initiated Date
    2003-07-10
  • Event Date Posted
    2003-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29125
  • 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
  • Reason
    Product's sterility is compromised due to a failed sterility audit.
  • Action
    Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.

Device

Device Recall Blue Torch
  • Model / Serial
    Lot Number: JCQ3141 EXpiration Date:May 2004
  • Distribution
    NY, TX
  • Product Description
    CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile || Part Number: 8305
  • Manufacturer
    Blue Torch Medical Technologies

Manufacturer

Blue Torch Medical Technologies
  • Manufacturer Address
    Blue Torch Medical Technologies, 200 Homer Avenue, Ashland Technology Center, Ashland MA 01721
  • Source
    USFDA