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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract. Lot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798 Class II Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. 27 Z-1672-2013
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract. Lot Number: 15982017, 15963887, 16034014 Class II Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. 15 units Z-1673-2013
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