Recall Z-1541-2012 ยท KZE Injector, Fluid, Non-Electrically Powered
CaridianBCT, Inc.
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.
| Date | May 11, 2012 (initiated Jun 1, 2010) |
| Status | Terminated |
| 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. |
| 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 | 2278 units |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090003 | ZETAJET Bioject, Inc., Apr 2, 2009 |