BEUDAMED
    FDA Recall Terminated

    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

    Recall: Z-0980-2013 · Initiated December 18, 2012

    Recall

    Recall Number
    Z-0980-2013
    Event Number
    63951
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 18, 2012
    Posted
    March 28, 2013
    Terminated
    August 1, 2016
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

    Reason

    Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

    Action

    Cardinal Health sent an Urgent Product Recall letter dated December 18, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immedaitely stop using affected product and discard any product that may be on hand, return the enclosed acknowledgement form, notify any customers to whom you may have distributed product affected by this recall, and contact the appropriate Customer Service group to arrange for credit of any affected product discarded. For questions contact Cardinal Health Professional Services at 800-292-9332.

    Distribution

    Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.

    Quantity

    Cat. No. 4FS30SSA: 7488; Cat. No. 4FS31SSA: 48; Cat. No. 4MM30SSA: 6336