Injector, Fluid, Non-Electrically Powered
FDA adverse event reports and recall history for injector, fluid, non-electrically powered (product code KZE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 467
- Deaths
- 2
- Injuries
- 151
- Malfunctions
- 139
Reports per year
Source: FDA adverse event reports by year received, 2004–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2012-05-11TerminatedSoftware design
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.
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.
Monitor injector, fluid, non-electrically powered automatically
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