Reported Mar 28, 2018 · Terminated
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Boston Scientific Corporation
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: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
- Lot codes and dates
- 21
68 of 68 codes
210713492118619921264281213384932107250621186874212648262133996921097205211892162126862821346857210999132119233221269880213483692110180921194784212750092134865521104860211964272127918321351508211062122119681521280166213541382111166721197475212824192135512821112353211983552128430221356067211201662120116421285174213594952112146721203598212857082136085721125598212047622128728321361914211298632120791621291325213664692113458521210287212919032136894121136699212121512129599021372468
21501442121837921305351213778272115093221220903213073212138069821156170212212472130896321381638211593962122628221310860213853272116049621227147213113612138716421163684212339492131302521387745
116486121235402213133922139131921165772212379292131551821393249211687292124054621316968213939002116997721241587213170172139501521170814212459842132282821395016211740262124677021324197214010472117584521249893213248512140104821176842212519682132902121401049211803432125300121329708214139402118125321254244213322292141475021181677212572142133484821420240211860022126091521335787
- Amount recalled
- 5026
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
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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