Events

Recall of Device Recall AirFlow, Infant Resuscitator

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
    63347
  • Event Risk Class
    Class 1
  • Event Number
    Z-0180-2013
  • Event Initiated Date
    2012-07-11
  • Event Date Posted
    2012-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114244
  • 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
    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
  • Action
    VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.

Device

Device Recall AirFlow, Infant Resuscitator
  • Model / Serial
    Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, OH, NY and TN.
  • Product Description
    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 || The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Manufacturer Address
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
  • Source
    USFDA