Reported Jun 8, 2016 · Terminated
Video Duodenoscope
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?
- Video Duodenoscope
- Lot codes and dates
423 of 423 codes
A110021A110022A110023A110024A110025A110026A110027A110028A110029A110030A110031A110032A110033A110034A110035A110036A110037A110038A110039A110043A110046A110051A110055A110056A110057A110058A110059A110060A110061A110062A110063A110064A110065A110067A110068A110070A110071A110072A110073A110074A110075A110076A110077A110078A110079A110080A110081A110082A110083A110086A110087A110088A110089A110090A110091A110092A110095A110098A110099A110100
- Amount recalled
- 423 units
Where it was sold
- Nationwide
Why it was recalled
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
This product could cause temporary or reversible health problems — stop using it.
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