BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311054 Legacy Part number: 478605

    Recall: Z-1257-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1257-2015
    Event ID
    70287
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    January 22, 2015
    Classification Date
    March 6, 2015
    Termination Date
    April 13, 2016
    Address
    2 Edgewater Drive, N/A, Norwood, MA, 02062, United States

    Description

    Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311054 Legacy Part number: 478605

    Reason

    Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution. US Nationwide, Australia, Austria, Belgium, Bosnia, Herzegovina, Canada, Colombia, Croatia, Curacao, Czech Republic, Estonia, Finland, France, Georgia, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates.

    Quantity

    32384