BEUDAMED
    FDA Recall Terminated

    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

    Recall: Z-1959-2019 · Initiated January 28, 2019

    Recall

    Recall Number
    Z-1959-2019
    Event Number
    82986
    Firm
    Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
    FEI Number
    2027111
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 28, 2019
    Terminated
    June 12, 2020
    Address
    Margarita, CA, 92688-2650

    Description

    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

    Reason

    The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

    Action

    Each US customer was notified via, "Urgent: Medical Device Recall" letter sent via UPS on January 28, 2019. All international consignees are in the process of being notified. The firm request customers compete the following actions: - Check your inventory for recalled product. - Complete the attached Recall Notification Confirmation Form (Page 2) to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. - If no product is being returned, please indicate on the Recall Notification Confirmation Form - If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 3 of the Recall Notification Confirmation Form. - Return the Recall Notification Confirmation Form to Applied Medical by emailing it to [email protected] or faxing it to (949) 713-8205. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical.

    Distribution

    Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland

    Quantity

    2,016 units