BEUDAMED
    FDA Recall Terminated

    Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.

    Recall: Z-0649-2013 · Initiated November 2, 2012

    Recall

    Recall Number
    Z-0649-2013
    Event Number
    63896
    Firm
    California Medical Laboratories Inc
    FEI Number
    1000135553
    Product Code
    DTS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 2, 2012
    Posted
    January 7, 2013
    Terminated
    March 4, 2013
    Address
    1570 Sunland Ln, Costa Mesa, CA, 92626-1515

    Description

    Sterile Rigid Tip Suction Wand 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.

    Action

    CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.

    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

    S112462=995 units & S111480 1430 units