Device evidence

device-recall:cfres:203764

Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; 3. Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100;

Official recall number

Z-0363-2024

Evidence summary

Product code: BTM
Recall status: Open, Classified
Event initiated: October 11, 2023
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0363-2024