Events

Recall of Edwards Protection Cannulae Monitoring and Infusion Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences 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
    57143
  • Event Risk Class
    Class 2
  • Event Number
    Z-0542-2011
  • Event Initiated Date
    2010-10-19
  • Event Date Posted
    2010-12-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95493
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Reason
    Monitoring and infusion set connectors may break during manipulation.
  • Action
    Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.

Device

Edwards Protection Cannulae Monitoring and Infusion Set
  • Model / Serial
    Lot No.: 58803802, 58851054, 58881366
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
  • Product Description
    Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

Edwards Lifesciences Llc
  • Manufacturer Address
    Edwards Lifesciences Llc, 12050 Lone Peak Parkway, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA