BEUDAMED
    FDA Enforcement Class II Terminated

    Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) Product Usage: Disposal system for counting of used surgical blades and needles.

    Recall: Z-0981-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0981-2013
    Event ID
    63951
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    December 18, 2012
    Classification Date
    March 28, 2013
    Termination Date
    August 1, 2016
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726, United States

    Description

    Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA) 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.

    Code Info

    Catalog Number: 3FS60SSA Lot Numbers: all lot numbers less than or equal to 898712 Catalog Number: 3FS61SSA Lot Numbers: all lot numbers less than or equal to 898714 Catalog Number: 3MM60SSA Lot Numbers: all lot numbers less than or equal to 931754

    Distribution

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

    Quantity

    Cat. No. 3FS60SSA: 7,560; Cat. No. 3FS61SSA: 14,184; Cat. No. 3MM60SSA: 12,384