BEUDAMED
    FDA Recall Terminated

    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.

    Recall: Z-0636-2014 · Initiated November 12, 2013

    Recall

    Recall Number
    Z-0636-2014
    Event Number
    67005
    Firm
    Ansell Sandel Medical Industries LLC
    FEI Number
    3004125670
    Product Code
    GDZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 12, 2013
    Posted
    January 8, 2014
    Terminated
    April 6, 2016
    Address
    19736 Dearborn St, Chatsworth, CA, 91311-6509

    Description

    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.

    Reason

    Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

    Action

    The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email [email protected]. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email [email protected]

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.

    Quantity

    15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)