Events

Recall of VCARE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventlab 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
    26369
  • Event Risk Class
    Class 3
  • Event Number
    Z-0982-03
  • Event Initiated Date
    2003-04-15
  • Event Date Posted
    2003-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27574
  • 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, Manual (Resuscitator) - Product Code BTM
  • Reason
    Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
  • Action
    Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.

Device

VCARE
  • Model / Serial
    Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
  • Product Description
    V*CARE, Infant Resuscitator, with 40 cm H¿O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Manufacturer Address
    Ventlab Corporation, 2934 Hwy 601 North, Mocksville NC 27028
  • Source
    USFDA