Events

Recall of MediChoice Umbilical cord clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cypress Medical Products LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64898
  • Event Risk Class
    Class 2
  • Event Number
    Z-1273-2013
  • Event Initiated Date
    2013-04-15
  • Event Date Posted
    2013-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117289
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Clamp, umbilical - Product Code HFW
  • 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.

Device

MediChoice Umbilical cord clamp
  • Model / Serial
    Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of VA only.
  • Product 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.
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • Manufacturer Address
    Cypress Medical Products LLC, 1202 S Il Route 31, Mchenry IL 60050
  • Manufacturer Parent Company (2017)
    Mckesson Corporation
  • Source
    USFDA