BEUDAMED
    FDA Enforcement Class II Terminated

    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.

    Recall: Z-0318-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0318-2016
    Event ID
    72450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TZ Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 14, 2015
    Classification Date
    November 18, 2015
    Termination Date
    October 24, 2016
    Address
    17750 SW Upper Boones Ferry Rd Ste 150, N/A, Portland, OR, 97224-7086, United States

    Description

    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.

    Reason

    During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k

    Code Info

    Lot Numbers: 2012-0809; 2012-0903; 2012-1011.

    Distribution

    US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.

    Quantity

    10,180 units