Reported Jul 6, 2016 · Terminated
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract.…
Pentax Medical Company
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 Medical Company · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs
- tissues and subsystemsEsophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations
- Lot codes and dates
Model #'s EG-3870CIKEC-3870CILK
- Amount recalled
- 17 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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