Events

Recall of Device Recall Gambro

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
    68788
  • Event Risk Class
    Class 2
  • Event Number
    Z-2198-2014
  • Event Initiated Date
    2014-07-18
  • Event Date Posted
    2014-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128672
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    Gambro initiated a field action on the prisma and prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
  • Action
    Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.

Device

Device Recall Gambro
  • Model / Serial
    Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
  • 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