Reported Feb 28, 2018 · Terminated
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are…
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?
- Pentax Video Duodenoscope ModelED-3490TK (UDI
- of design being recalled04961333232420) 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
- All Serial Numbers
- Amount recalled
- 559
Where it was sold
Why it was recalled
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
This product could cause temporary or reversible health problems — stop using it.
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