Reported Dec 8, 2021 · Ongoing
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of…
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?
- HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- UPNM00545900
- Lot codes and dates
- GTIN08714729283812
- Lot Numbers
347 of 347 codes
255767192557672025576721255767692561156425612669256126702561267125612673256126742562337725623378256233792562338025623381256233822562338325623384256401152564981325649816256788212567882625678831256788362568009625704209257042102570421125704212257042132570421425704215257042162573914625739147257391492573915025771761257717622577176325771764257717652577176625771767257717682577176925771770257717712583608125836082258785532587855425878555258947832591627025916271259164452591644625940122
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
This product could cause temporary or reversible health problems — stop using it.
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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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