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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Recall Number Z-1673-2013
Classification Class II
Code Info Lot Number: 15982017, 15963887, 16034014
Product Distributed Qty 15 units
Reason For Recall Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Event Detail

Event Id 65317
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Marlborough
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.