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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 Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
Recall Number Z-1786-2014
Classification Class II
Code Info Product Code 18400, Lot No. 01A1400037
Product Distributed Qty 450
Reason For Recall Several complaints were received for the metal support tube missing from the cholangiogram catheter.

Event Detail

Event Id 68332
Product Type Devices
Status Ongoing
Recalling Firm Teleflex Medical
City Durham
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.