FDA-Device2015-07-08Class II
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.
Boston Scientific Corporation
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.
Sold states
Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
Affected count
39 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2015Don't want to check this manually?
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