Events

Recall of Device Recall TruChoice and 3T Medical Systems Adjustable Vent Valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alliant Enterprises LLC.

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
    59524
  • Event Risk Class
    Class 2
  • Event Number
    Z-3060-2011
  • Event Initiated Date
    2011-07-21
  • Event Date Posted
    2011-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103020
  • 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
    Cpb check valve, retrograde flow, in-line - Product Code MJJ
  • Reason
    The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together.
  • Action
    Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.

Device

Device Recall TruChoice and 3T Medical Systems Adjustable Vent Valve
  • Model / Serial
    Lot # 2011-06-18 thru 2014-06-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
  • Product Description
    Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUANTITY: 100, DESCRIPTION: NONADJUSTABLE VENT VALVE, NON-STERILE; AND and 3-T Medical Systems, Catalog #035NS, Non-Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE || The TrueChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.
  • Manufacturer
    Alliant Enterprises LLC

Manufacturer

Alliant Enterprises LLC
  • Manufacturer Address
    Alliant Enterprises LLC, 8850 M 89, Richland MI 49083-8558
  • Manufacturer Parent Company (2017)
    Alliant Enterprises Llc
  • Source
    USFDA