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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Recall Number Z-0898-2013
Classification Class II
Code Info 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.
Product Distributed Qty 785
Reason For Recall 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.

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 Letter
Distribution Pattern USA Nationwide Distribution including the state of PA.
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