Events

Recall of VORTRAN Automatic Resuscitator, VARPlus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vortran Medical Technology 1, 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
    77072
  • Event Risk Class
    Class 2
  • Event Number
    Z-2092-2017
  • Event Initiated Date
    2017-04-20
  • Event Date Posted
    2017-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154926
  • 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
    Ventilator, emergency, powered (resuscitator) - Product Code BTL
  • Reason
    Vortran received a customer complaint that the spin-nut-dss connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
  • Action
    Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.

Device

VORTRAN Automatic Resuscitator, VARPlus
  • Model / Serial
    Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, MS, FL
  • Product Description
    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; || Model PCE-5012; Qty: 10 each. || Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory || support.
  • Manufacturer
    Vortran Medical Technology 1, Inc

Manufacturer

Vortran Medical Technology 1, Inc
  • Manufacturer Address
    Vortran Medical Technology 1, Inc, 21 Goldenland Court Ste 100, Sacramento CA 95834-2427
  • Manufacturer Parent Company (2017)
    Vortran Medical Technology 1 Inc
  • Source
    USFDA