BEUDAMED
    FDA Recall Terminated

    Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.

    Recall: Z-0925-06 · Initiated April 20, 2006

    Recall

    Recall Number
    Z-0925-06
    Event Number
    35228
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 20, 2006
    Posted
    May 31, 2006
    Terminated
    September 26, 2012
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code EPS11.

    Reason

    There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

    Action

    The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.

    Distribution

    The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela.

    Quantity

    48 cases/6 devices per case.