BEUDAMED
    FDA Enforcement Class II Ongoing

    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

    Recall: Z-1038-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1038-2019
    Event ID
    82039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2019
    Initiation Date
    January 9, 2019
    Classification Date
    March 21, 2019
    Address
    7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, 27409-9076, United States

    Description

    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

    Reason

    An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

    Code Info

    Product Code/REF Number: 504159; Lot Codes: 176482, 189027

    Distribution

    Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.

    Quantity

    124,000 units total