Events

Recall of Surge Medical Solutions Retrograde Cardioplegia Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surge Medical Solutions, 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
    37806
  • Event Risk Class
    Class 2
  • Event Number
    Z-0893-2007
  • Event Initiated Date
    2007-04-17
  • Event Date Posted
    2007-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51595
  • 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
    Cannula, cardioplegia - Product Code DWF
  • Reason
    The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
  • Action
    Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.

Device

Surge Medical Solutions Retrograde Cardioplegia Cannula
  • Model / Serial
    All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
  • Product Description
    Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S.
  • Manufacturer
    Surge Medical Solutions, LLC

Manufacturer

Surge Medical Solutions, LLC
  • Manufacturer Address
    Surge Medical Solutions, LLC, 3710 Sysco Court S.E., Grand Rapids MI 49512
  • Source
    USFDA