Drug recall
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower…
FDA recall event 73985 · Class II · Pentax Medical Company
Key facts
| Event ID | 73985 |
|---|---|
| Recall numbers | Z-2275-2016, Z-2276-2016, Z-2277-2016, Z-2278-2016, Z-2279-2016, Z-2280-2016 |
| Recalling firm | Pentax Medical Company |
| Product type | Devices |
| Products | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs…, Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs…, Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and…, Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs…, Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. |
| Initiation date | Apr 6, 2016 |
| Report date | Aug 3, 2016 |
| Termination date | Jul 17, 2017 |
| City | Montvale |
| State | NJ |
| Country | United States |
| FEI number | 1000080301 |
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: