Events

Recall of Device Recall FASTx Sternal Intraosseous Device

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

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
    59019
  • Event Risk Class
    Class 2
  • Event Number
    Z-2687-2011
  • Event Initiated Date
    2010-11-05
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100841
  • 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, hypodermic, single lumen - Product Code FMI
  • Reason
    Device failed to operate; the insertion of the infusion tube of the fastx sternal intraosseous device was not achieved in live subjects.
  • Action
    Pyng Medical Corp. sent a "FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx. Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.

Device

Device Recall FASTx Sternal Intraosseous Device
  • Model / Serial
    3 lot numbers: "20100609", "20100610", and 20100611". Format is "YYYYMMXX" where YYYY is the year of manufacture, MM is the month, and XX is a sequential number identifying different lots manufactured in the same month.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
  • Product Description
    The product is the "FASTx Sternal Intraosseous Device". || The expiration date for the recalled products is end of June, 2012. || The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
  • Manufacturer
    Pyng Medical Corporation

Manufacturer

Pyng Medical Corporation
  • Manufacturer Address
    Pyng Medical Corporation, 13511 Crestwood Pl Rm 7, Richmond Canada
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA