BEUDAMED
    FDA Enforcement Class II Terminated

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    Recall: Z-1898-2012 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1898-2012
    Event ID
    62272
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SALTER LABS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 4, 2012
    Initiation Date
    May 30, 2012
    Classification Date
    June 27, 2012
    Termination Date
    July 27, 2012
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300, United States

    Description

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    Reason

    A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.

    Code Info

    Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.

    Distribution

    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.

    Quantity

    242 cases