Events

Recall of Device Recall Trima Accel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CaridianBCT, 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
    53196
  • Event Risk Class
    Class 2
  • Event Number
    Z-1541-2012
  • Event Initiated Date
    2010-06-01
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109058
  • 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
    Injector, fluid, non-electrically powered - Product Code KZE
  • Reason
    Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection tbv limit, and to be in compliance with the most current fda guidance for post donation platelet count targets.
  • Action
    CaridianBCT sent a Letter notification dated March 2011 to consignees The letter identified the upcoming software updates to version 6.0.1 as well as operations manual changes. For questions contact your CaridianBCT Representative, the CaridianBCT Support Center at +1-877-339-4228 or 1-303-231-4357 or your local CaridianBCT Customer Service office.

Device

Device Recall Trima Accel
  • Model / Serial
    All serial numbers and lots manufactured from 1997 to present.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. || Product Usage: || Automated Blood Collection System for use in humans.
  • Manufacturer
    CaridianBCT, Inc.

Manufacturer

CaridianBCT, Inc.
  • Manufacturer Address
    CaridianBCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Source
    USFDA