Device recall
Z-1125-2013: Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE…
FDA device recall · Class II · Instrumentation Industries Inc
Key facts
| Recall number (Z-number) | Z-1125-2013 |
|---|---|
| Recall event | 64568 |
| Product | Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are… |
| Product code | BTL |
| Recalling firm | Instrumentation Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2013 |
| 510(k) numbers | K991785 |
| FEI number | 2518436 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database