Device recall
Z-2374-2015: SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated…
FDA device recall · Class I · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-2374-2015 |
|---|---|
| Recall event | 71551 |
| Product | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing… |
| Product code | PDR |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 2, 2016 |
| PMA numbers | P080009 |
| FEI number | 1527736 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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