Events

Recall of Device Recall Kendall Tyco/healthcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kendall Healthcare Products Co.

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
    27842
  • Event Risk Class
    Class 3
  • Event Number
    Z-0234-04
  • Event Initiated Date
    2003-12-02
  • Event Date Posted
    2003-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30620
  • 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
    Catheter, Hemodialysis, Non-Implanted - Product Code MPB
  • Reason
    Product is mislabeled to catheter length. product labeled as a 13.5 fr x 19.5 cm may contain a 13.5 fr x 16.0 cm.
  • Action
    Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.

Device

Device Recall Kendall Tyco/healthcare
  • Model / Serial
    Lot Number: 140774
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IL, MA, OH, TN, TX, VA
  • Product Description
    Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm || For hemodialysis, apheresis, and infusion || Reference: 8888-135195
  • Manufacturer
    Kendall Healthcare Products Co

Manufacturer

Kendall Healthcare Products Co
  • Manufacturer Address
    Kendall Healthcare Products Co, 15 Hampshire St, Mansfield MA 02048-1113
  • Source
    USFDA