BEUDAMED
    FDA Recall Terminated

    Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number: 010987-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.

    Recall: Z-1350-2012 · Initiated December 1, 2011

    Recall

    Recall Number
    Z-1350-2012
    Event Number
    61143
    Firm
    Oridion Medical
    FEI Number
    3001227743
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 1, 2011
    Posted
    March 30, 2012
    Terminated
    June 4, 2012
    Address
    1987 Ltd. 7 Hamarpe St. P.O. Box 45025, Har Hotzvim Industrial Park Jerusalem Israel

    Description

    Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number: 010987-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.

    Reason

    Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet

    Action

    Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at [email protected]

    Distribution

    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.

    Quantity

    84 boxes (2100 untis)