Events

Recall of Device Recall Hemodialysis Clinical Kit

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

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
    25023
  • Event Risk Class
    Class 2
  • Event Number
    Z-0307-03
  • Event Initiated Date
    2002-11-13
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25028
  • 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
  • Reason
    Gambro's clinicalkit 15g safety kits contain the nipro safetouch safety fistula needles currently being recalled by nipro for leakage problems.
  • Action
    All consignees were notified by telephone and fax on 11/13/2002.

Device

Device Recall Hemodialysis Clinical Kit
  • Model / Serial
    Gambro ClinicalKit Safety Kit 15G. Catalog No. 0141080405C. Lots 05H154001, 04H154007, 04H154010, 04H154011..
  • Distribution
    Domestic distribution to CO, IL, MO and VA. No military, government or foreign consignees.
  • Product Description
    Gambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
  • Manufacturer
    Gambro Renal Products

Manufacturer

Gambro Renal Products
  • Manufacturer Address
    Gambro Renal Products, 10810 West Collins Ave., Lakewood 80215
  • Source
    USFDA