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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
Recall Number Z-1732-2014
Classification Class II
Code Info Product Code: ECK103, Lot number: 02A1402484
Product Distributed Qty 1000 eaches
Reason For Recall Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

Event Detail

Event Id 68350
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of CA, FL, OH and OK.