Drug recall
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two…
FDA recall event 74311 · Class II · Custom Ultrasonics, Inc.
Key facts
| Event ID | 74311 |
|---|---|
| Recall numbers | Z-2130-2016 |
| Recalling firm | Custom Ultrasonics, Inc. |
| Product type | Devices |
| Products | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. |
| Initiation date | May 6, 2016 |
| Report date | Jul 13, 2016 |
| Termination date | Apr 18, 2017 |
| City | Ivyland |
| State | PA |
| Country | United States |
| FEI number | 2523209 |
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: