BEUDAMED
    FDA Recall Terminated

    Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.

    Recall: Z-0396-2010 · Initiated September 23, 2009

    Recall

    Recall Number
    Z-0396-2010
    Event Number
    53694
    Firm
    Surgical Devices/Covidien
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 23, 2009
    Posted
    November 23, 2009
    Terminated
    March 8, 2010
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.

    Reason

    Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

    Action

    The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.

    Distribution

    The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.

    Quantity

    78,579 units