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Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00
Recalled July 8, 2015 · FDA recall Z-1941-2015 · Boston Scientific
Hazard
One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. · FDA Class II
Units
39 units
Sold at
Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
Description
One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Product
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →