BEUDAMED
    FDA Enforcement Class II Terminated

    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.

    Recall: Z-1273-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1273-2013
    Event ID
    64898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cypress Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 15, 2013
    Initiation Date
    April 15, 2013
    Classification Date
    May 8, 2013
    Termination Date
    August 10, 2015
    Address
    1202 S Il Route 31, N/A, Mchenry, IL, 60050, United States

    Description

    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.

    Reason

    Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.

    Code Info

    Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.

    Distribution

    US Distribution to the state of VA only.

    Quantity

    150 Cases (75,000 Units)