Events

Recall of Medrad(R) Continuum MR Infusion System Primary Spike Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad Inc.

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
    61734
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2013
  • Event Initiated Date
    2012-04-18
  • Event Date Posted
    2012-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108840
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Bayer healthcare is recalling all medrad(r) continuum mf infusion system tubing sets (macrobore and microbore), catalog numbers mik200a, mil 200b, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. the firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any continuum pump, may result in flow rate accuracy performance issues.
  • Action
    The firm, Bayer HealthCare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 17, 2012 via the USPS certified mail to its consignees/customers. The firm expanded the recall on May 11, 2012 and sent a second letter entitled "EXPANDED URGENT MEDICAL DEVICE RECALL" to its affected consignees/customers notifying them of the additional issue. The letters described the product, problem and actions to be taken. The customers were instructed to return pump now; contact customer support at 1-877-229-3767 for a return goods authorization (RGA); complete and return Response Form, include RGA numbers, via Fax to Bayer Compliance at 412-4060942, and/or wait to return the pump when they begin contacting customers with this subset of pumps in August to make arrangements for a replacement pump. If you have questions, please contact our customer support team at 1-877-229-3767 or visit www.medrad.com for more information.

Device

Medrad(R) Continuum MR Infusion System Primary Spike Set
  • Model / Serial
    Catalog number - Primary Spike Set: 3015158. See firm's website - www.medrad.com for specific serial and lot numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.
  • Product Description
    Medrad(R) Continuum MR Infusion System Primary Spike Set || Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA