BEUDAMED
    FDA Recall 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 · Initiated April 15, 2013

    Recall

    Recall Number
    Z-1273-2013
    Event Number
    64898
    Firm
    Cypress Medical Products LLC
    FEI Number
    1451040
    Product Code
    HFW
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 15, 2013
    Posted
    May 8, 2013
    Terminated
    August 10, 2015
    Address
    1202 S Il Route 31, Mchenry, IL, 60050

    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.

    Action

    Cypress Medical Products sent an "Urgent Voluntary Medical Device Recall" notification and an associated response form dated April 15, 2013 to their only customer for this device - Owens & Minor. The product problem was identified and recommended actions provided.

    Distribution

    US Distribution to the state of VA only.

    Quantity

    150 Cases (75,000 Units)