BEUDAMED
    FDA Enforcement Class II Terminated

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    Recall: Z-2595-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2595-2014
    Event ID
    69066
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Catheter Connections, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    August 5, 2014
    Classification Date
    September 5, 2014
    Termination Date
    October 8, 2014
    Address
    615 Arapeen Dr Ste 302A, N/A, Salt Lake City, UT, 84108, United States

    Description

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    Reason

    Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

    Code Info

    Lot 1406509

    Distribution

    US Distribution to states of: CT, GA, MD, and PA. .

    Quantity

    24,910 units