BEUDAMED
    FDA Recall Terminated

    Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;

    Recall: Z-1333-2012 · Initiated February 16, 2012

    Recall

    Recall Number
    Z-1333-2012
    Event Number
    61329
    Firm
    Oridion Medical
    FEI Number
    3001227743
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 16, 2012
    Posted
    March 29, 2012
    Terminated
    September 13, 2013
    Address
    1987 Ltd. 7 Hamarpe St. P.O. Box 45025, Har Hotzvim Industrial Park Jerusalem Israel

    Description

    Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;

    Reason

    CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

    Action

    Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.

    Distribution

    Nationwide Distribution

    Quantity

    2 million