KZEClass II

Injector, Fluid, Non-electrically Powered

General Hospital · 21 CFR 880.5430

MDR events467All time

Recalls1All time

Registered firms13Currently listed

510(k) clearances53All time

Recent MDR events

467 adverse event reports on file

Event type breakdown

Injury151

Malfunction139

Other112

Unspecified63

Death2

Most-reported manufacturers

Eli Lilly And Co.134 Eli Lilly And Company51 Genentech, Inc.51 Novo Nordisk A/s28 Medi-ject Corp.18 Eli Lilly And Co17 Novo Nordisk A/s, Medical Systems16 Becton Dickinson14

Recalls

1 recall events for this product code

CaridianBCT, Inc.
TerminatedMay 11, 2012
Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA.
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.
Z-1541-2012 · View FDA record ↗

Registered firms

13 firms currently registered for this product code

510(k) clearances

53 clearances for this product code