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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Boston Scientific, RunWay" Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Recall Number Z-1164-2014
Classification Class II
Code Info 2013040058
Product Distributed Qty 7
Reason For Recall Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay" Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date, Boston Scientific has received one complaint for this issue. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

Event Detail

Event Id 67658
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Maple Grove
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern TX and Russia