Events

Recall of Device Recall Cartridge Blood Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gambro Renal Products, 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
    48148
  • Event Risk Class
    Class 2
  • Event Number
    Z-1860-2008
  • Event Initiated Date
    2008-05-02
  • Event Date Posted
    2008-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70909
  • 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
    Tubing set with and without anti-regurgitation valve - Product Code FJK
  • Reason
    Dialysis tubing sets may have occlusions restricting blood flow.
  • Action
    Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets.

Device

Device Recall Cartridge Blood Set
  • Model / Serial
    Serial numbers: 04P158215 and below, 03P158XXX (all lots)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
  • Product Description
    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
  • Manufacturer
    Gambro Renal Products, Inc.

Manufacturer

Gambro Renal Products, Inc.
  • Manufacturer Address
    Gambro Renal Products, Inc., 14143 Denver West Pkwy, Lakewood CO 80401-3116
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA