Events

Recall of BMC RF Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baylis Medical Company 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
    64250
  • Event Risk Class
    Class 2
  • Event Number
    Z-0879-2013
  • Event Initiated Date
    2012-10-04
  • Event Date Posted
    2013-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115670
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • Reason
    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. the cannulas were not used on any patients, as the unsealed packages.
  • Action
    A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.

Device

BMC RF Cannula
  • Model / Serial
    Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International distribution to the country of Australia.
  • Product Description
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
  • Manufacturer
    Baylis Medical Company Inc.

Manufacturer

Baylis Medical Company Inc.
  • Manufacturer Address
    Baylis Medical Company Inc., 5160 Explorer Drive #33, Mississauga Canada Ontario
  • Manufacturer Parent Company (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA