BEUDAMED
    FDA Recall Terminated

    Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

    Recall: Z-0025-2009 · Initiated June 25, 2008

    Recall

    Recall Number
    Z-0025-2009
    Event Number
    49445
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 25, 2008
    Posted
    October 7, 2008
    Terminated
    March 26, 2012
    Address
    Margarita, CA, 92688

    Description

    Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

    Reason

    Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).

    Action

    Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.

    Distribution

    Nationwide and Canada distribution.

    Quantity

    14,113 total