Reported Dec 8, 2021 · Ongoing
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter…
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 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- UPNM00545920
- Lot codes and dates
- GTIN08714729283836
- Batches
396 of 396 codes
255767702557688125576882255768832557688425576885256087622562338625623387256233882562338925623390256233912562339225623393256233942562339525623396256233972562339825649814256498172564982025649821256498252564982625649830256498312567882325678827256788322567883725680097257042172570421825704219257042202570422125704222257042232573915225739153257391542573915525739157257391582577177325771774257717752577177625771777257717782583608325836084258360852583608625836087258360882583608925836090
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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