BEUDAMED
    FDA Recall Terminated

    CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626

    Recall: Z-1177-2008 · Initiated January 24, 2008

    Recall

    Recall Number
    Z-1177-2008
    Event Number
    46745
    Firm
    California Medical Laboratories Inc
    FEI Number
    1000135553
    Product Code
    DTS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 24, 2008
    Posted
    June 11, 2008
    Terminated
    March 5, 2013
    Address
    1570 Sunland Ln, Costa Mesa, CA, 92626-1515

    Description

    CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626

    Reason

    Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

    Action

    CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.

    Distribution

    Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.

    Quantity

    31,124 units of all models