Device recall
Z-0802-2012: BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use…
FDA device recall · Class I · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Recall number (Z-number) | Z-0802-2012 |
|---|---|
| Recall event | 60372 |
| Product | BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable… |
| Product code | GXY |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 13, 2013 |
| 510(k) numbers | K062692 |
| FEI number | 2936999 |
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