Events

Recall of Device Recall Ventlabassembled Anesthesia breathing bags

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
    48958
  • Event Risk Class
    Class 2
  • Event Number
    Z-2324-2008
  • Event Initiated Date
    2007-12-05
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72404
  • 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
    Reservoir bag - Product Code BTC
  • Reason
    During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
  • Action
    Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility. Contact James Cochie at 336-753-5000 if you have questions.

Device

Device Recall Ventlabassembled Anesthesia breathing bags
  • Model / Serial
    (NC Facility): Part #720057B (3 Liter bags), Lot #63069, 64872, 65226, 66781, 67068, 67068; Part #720058B (2 Liter bags), Lot#63660, 64877, 65225, 68752; Part #720059B (1Liter bags), Lot#63661, 64878, 65227. (China Facility): Part #720057B, Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005; Part #720059B, Lot #1B0001, 1B0002, 1B0003; and Part #720058B, Lot #2B0002
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL
  • Product Description
    Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
  • Manufacturer
    Ventlab Corporation

Manufacturer

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