BEUDAMED
    FDA Enforcement Class II Terminated

    Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.

    Recall: Z-0650-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0650-2013
    Event ID
    63896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    California Medical Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2013
    Initiation Date
    November 2, 2012
    Classification Date
    January 7, 2013
    Termination Date
    March 4, 2013
    Address
    1570 Sunland Ln, Costa Mesa, CA, 92626-1515, United States

    Description

    Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.

    Reason

    California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

    Code Info

    Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N

    Distribution

    Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.

    Quantity

    S112468N=1000 units, S120196N=1400 units, & S120197N=1200 units