BEUDAMED
    FDA Recall Terminated

    Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green, product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green, product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product code iR60B4.

    Recall: Z-0405-2010 · Initiated September 23, 2009

    Recall

    Recall Number
    Z-0405-2010
    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

    Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green, product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green, product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product code iR60B4.

    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

    21,958units