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U.S. Department of Health and Human Services

Class 2 Device Recall Trima Accel

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 Class 2 Recall
Trima Accel
see related information
Date Posted May 11, 2012
Recall Status1 Terminated on July 25, 2012
Recall Number Z-1541-2012
Recall Event ID 53196
Premarket Notification
510(K) Number
K090003 
Product Classification Injector, Fluid, Non-Electrically Powered - Product Code KZE
Product 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.
Code Information All serial numbers and lots manufactured from 1997 to present.
Recalling Firm/
Manufacturer
CaridianBCT, Inc.
10811 W Collins Ave
Lakewood, Colorado 80215-4440
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 2278 units
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KZE and Original Applicant = BIOJECT, INC.
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