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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64458
Product Type Devices
Status Ongoing
Recalling Firm Vygon Corporation
City Montgomeryville
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015. Class II Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. 210 Z-0937-2013
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