Reported Jul 30, 2014 · Terminated
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope…
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?
- EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
- Lot codes and dates
- Model
81 of 81 codes
EG-3630UA01013E010080E110111E110159E110236A01017E010082E110116E110161E110237A01022E010084E110118E110167E110239A01025E010092E110120E110169E110240A01026E010093E110132E110172E110256A01028E010094E110134E110177E110277A01029E010095E110135E110179E110278A01031E010096E110138E110182E110282A01033E01037E110139E110187E110283A01036E01038E110140E110188E110285E010064E01039E110141E110193E110287E010066E01042E110144E110195
- E010078 E01062 E110157 E110219 Model
EG-3830UTE110067E110160E110204E110275E110374E110070E110163E110206E110277E110377E110074E110165E110212E110286E110379E110079E110168E110214E110289E110426E110082E110171E110224E110292E110428E110093E110172E110228E110295E110433E110095E110174E110230E110309E110439E110108E110183E110243E110310E110442E110126E110186E110255E110323E110444E110142E110189E110263E110331E110454E110152E110195E110265E110340E110517
- E110153 E110196 E110268 E110341 Model
FG-36UXA01014A01049A01079A01100A01166A01019A01053A01080A01104A01168A01020A01054A01081A01105A01174A01029A01055A01082A01116A01183A01030A01056A01084A01122A01184A01033A01057A01086A01126A01186A01036A01068A01092A01131A110260A01040A01070A01096A01137A110268
- A01046 A01074 A01098 A01142 Model
313 of 313 codes
EG-3870UTKA110013A110060A110095A110125A110154A110021A110061A110096A110126A110155A110022A110062A110098A110127A110156A110024A110063A110099A110128A110161A110025A110065A110100A110129A110162A110026A110067A110101A110130A110163A110028A110068A110104A110133A110164A110029A110069A110105A110134A110165A110031A110070A110106A110135A110166A110033A110071A110107A110138A110167A110038A110073A110108A110139A110168A110040A110076A110110A110140
- Model
- Amount recalled
- 531 units
Where it was sold
- Nationwide
Why it was recalled
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
This product could cause temporary or reversible health problems — stop using it.
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