BEUDAMED
    FDA Recall Terminated

    RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, 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.

    Recall: Z-0579-04 · Initiated February 3, 2004

    Recall

    Recall Number
    Z-0579-04
    Event Number
    28260
    Firm
    Rusch Inc
    FEI Number
    2429473
    Product Code
    CBP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 3, 2004
    Posted
    July 20, 2004
    Terminated
    March 21, 2006
    Address
    2450 Meadowbrook Pkwy, Duluth, GA, 30096-4635

    Description

    RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, 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.

    Reason

    Valve cap may become loose and enter the air circuitry.

    Action

    Consignees were notified on 2/3/2004 via certified mail and telephone.

    Distribution

    Nationwide and Canada

    Quantity

    13560 pieces