Drug recall
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and…
FDA recall event 71551 · Class I · Ethicon Endo-Surgery Inc
Key facts
| Event ID | 71551 |
|---|---|
| Recall numbers | Z-2374-2015 |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit. |
| Initiation date | May 13, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | May 2, 2016 |
| City | Blue Ash |
| State | OH |
| Country | United States |
| FEI number | 1527736 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: