Reported Jul 19, 2017 · Terminated
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and…
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues
- and subsystemsesophagus, stomach, duodenum, common bile, hepatic and cystic ducts
- Lot codes and dates
- Model NumbersEd-3490TK and ED-3270K
- Amount recalled
- 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
Where it was sold
Why it was recalled
Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
This product could cause temporary or reversible health problems — stop using it.
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