Events

Recall of Device Recall Gambro 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, Incorporated.

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
    67797
  • Event Risk Class
    Class 2
  • Event Number
    Z-1455-2014
  • Event Initiated Date
    2013-12-09
  • Event Date Posted
    2014-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126338
  • 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
    Set, tubing, blood, with and without anti-regurgitation - Product Code FJK
  • Reason
    Occluded heparin tubing events preventing anticoagulation dosing on the gambro cartridge blood sets.
  • Action
    On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.

Device

Device Recall Gambro Cartridge Blood Set
  • Model / Serial
    Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
  • Product Description
    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • Manufacturer Address
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA