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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Recall Number Z-1728-2013
Classification Class II
Code Info Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
Product Distributed Qty 40 units
Reason For Recall Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

Event Detail

Event Id 65505
Product Type Devices
Status Terminated
Recalling Firm Karl Storz Endoscopy America Inc
City Southbridge
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US distribution to: AZ, FL, IL, IN and TX.
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