Events

Recall of Device Recall CombiSet True Flow Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care North America.

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
    50491
  • Event Risk Class
    Class 2
  • Event Number
    Z-0859-2009
  • Event Initiated Date
    2008-11-25
  • Event Date Posted
    2009-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75493
  • 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
    Hemodialysis Blood Circuit and Accessories - Product Code KOC
  • Reason
    Port may crack and separate resulting in potential blood exposure/blood loss for the patient.
  • Action
    Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.

Device

Device Recall CombiSet True Flow Series
  • Model / Serial
    Lot number 8LR902 only
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) || Product Code: 03-2994-6 24 sets / case || CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

Fresenius Medical Care North America
  • Manufacturer Address
    Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA