BEUDAMED
    FDA Recall Terminated

    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

    Recall: Z-0866-2015 · Initiated November 17, 2014

    Recall

    Recall Number
    Z-0866-2015
    Event Number
    69910
    Firm
    Halyard Health
    FEI Number
    3011157493
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 17, 2014
    Posted
    December 24, 2014
    Terminated
    August 18, 2015
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190

    Description

    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.

    Reason

    The cuff inflation line may detach from the endotracheal tube during use.

    Action

    The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.

    Distribution

    Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.

    Quantity

    430 cases (10 tubes per case)