BEUDAMED
    FDA Recall Terminated

    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

    Recall: Z-0401-2019 · Initiated August 22, 2018

    Recall

    Recall Number
    Z-0401-2019
    Event Number
    81150
    Firm
    Safe N Simple, LLC
    FEI Number
    3008374791
    Product Code
    NAE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 22, 2018
    Terminated
    March 17, 2020
    Address
    5827 Terex, Clarkston, MI, 48346-1717

    Description

    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

    Reason

    The sterilization process used was unqualified.

    Action

    Safe n Simple extended the recall to the only customer that ordered the product in the lot numbers (see table). The firm provided a written notice to the customer mentioned in the table with specific instructions along with a phone conversation. Safe n Simple instructed the customer to provide the inventory level of SNS58315 and SNS58345 specific to lot numbers 18060564 and 18060563 respectively and to return such product to Safe N Simple LLC at Safe N Simple LLC expense. The effectiveness of the recall was good since the customer immediately responded by shipping all their inventory back to us.

    Distribution

    CA

    Quantity

    125 cases