Recall of Device Recall One Way Valve/Male to Female

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rusch 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Valve, Non-Rebreathing - Product Code CBP
  • Reason
    Valve cap may become loose and enter the air circuitry.
  • Action
    Consignees were notified on 2/3/2004 via certified mail and telephone.


  • Model / Serial
    Catalog No. 396799; Lot numbers: 010905, 011020, 020305, 020530, 020705, 020925, 030120, 031120, 030325, 030415.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Canada
  • Product Description
    One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot ***, SINGLE USE ONLY, Latex Free, Quantity 50 Each Manufactured for and Distributed by RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098, Made in Taiwan.
  • Manufacturer


  • Manufacturer Address
    Rusch Inc, 2450 Meadowbrook Pkwy, Duluth GA 30096-4635
  • Source