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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
Recall Number Z-0710-2014
Classification Class II
Code Info Lot Number:16231178
Product Distributed Qty 39 units
Reason For Recall Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Event Detail

Event Id 67139
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Marlborough
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (Nationwide) and Puerto Rico and Internationally.