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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64235
Product Type Devices
Status Ongoing
Recalling Firm Medical Components, Inc dba MedComp
City Harleysville
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide Distribution including the state of PA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits 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 This recall is being initiated due to the affected product being packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. 785 Z-0898-2013