Hurricane recall
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Why was Hurricane recalled?
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
- Product
- HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
- Recalling firm
- Boston Scientific Corporation
- Distribution
- US Nationwide distribution.
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)