Reported Dec 8, 2021 · Ongoing
HURRICANE RX DILATION BALLOON 8MM 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 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- UPNM00545940
- Lot codes and dates
- Batches
512 of 512 codes
256087602561267225649815256498182564982225649823256498272564982825649832256498332567882425678828256788292567883325678834256788382568009825680099257042242570422525704226257042272570422825704229257391592573916025739161257391622573916325739164257391652573916625739167257391682578824225789369257898012583609325836094258360952583609625836097258360982583609925836140258361412583614225836143258361442583614525878556258947802589478125894782259164572593948525939684259401262594012725940131
- GTIN08714729283850 Exp. 05/18/2022 to 05/31/2023
- Batches
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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