Events

Recall of Device Recall 4Way TPiece

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
    Recall
  • Event ID
    28260
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-04
  • Event Initiated Date
    2004-02-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31457
  • 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.

Device

Device Recall 4Way TPiece
  • Model / Serial
    Catalog No.: 395945, Lot numbers: 116040, 116039, 114795, 113887, 113886, 113232, 113230, 113095, 113027, 119110, 118134, 119988, 119989, 129179, 128393, 128028, 126119, 126118, 124951, 123197, 123198, 122461, 122033, 131793, 120731;
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450 Meadowbrook Parkway, Duluth, GA 30098***. Carton labeling was similar to individual unit labeling, except for, ***Qty 50 ea.
  • Manufacturer
    Rusch Inc

Manufacturer

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