Z-1541-2012

Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA

Name: Z-1541-2012 Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA
Creator: CaridianBCT, Inc.
Published: 2010-06-01
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2010-06-01 / Terminated / root cause: software

FDA source

CaridianBCT, Inc. began a recall of Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System... on 2010-06-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1541-2012
Status: Terminated
Initiated: 2010-06-01
Posted: 2012-05-11
Terminated: 2012-07-25
Recalling firm: Terumo BCT, Ltd
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.
Product code: KZE Injector, Fluid, Non-Electrically Powered
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: All serial numbers and lots manufactured from 1997 to present.

Product code KZE

K090003Class IIZetajetBioject, Inc. / cleared 2009-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)