BEUDAMED
    FDA Recall Terminated

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    Recall: Z-1182-2018 · Initiated November 3, 2017

    Recall

    Recall Number
    Z-1182-2018
    Event Number
    79402
    Firm
    Madison Polymeric Engineering
    FEI Number
    3001451466
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 3, 2017
    Terminated
    July 17, 2018
    Address
    965 W Main St, Branford, CT, 06405-3453

    Description

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    Reason

    Affected lots may have exceeded its microbial limits.

    Action

    Cygnus sent an Recall Letter dated November 3, 2017. Actions Required: 1. Immediately discontinue distribution of First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable). 2. Determine if any stock of the First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable) remains in your inventory. 3. Please complete the attached form and return to Cygnus Medical as indicated. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received the lots in the tables above between November 28, 2016 and January 11, 2017 with the letter provided. Once Cygnus Medical has received your completed form, if you have indicated you have any remaining product from these lots, we will issue a Return Goods Authorization, call tag, and/or FedEx/UPS account number. If you have questions regarding this matter, please contact Customer Service at 800-990-7489 or Quality Control at 203-488-4554 at x105 during business hours 8:30am-5:00pm Eastern Standard Time.

    Distribution

    US Distribution. .

    Quantity

    285 cases