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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Event Detail

Event ID 62238
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 2012-04-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit. Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015 Class II Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. 30 Z-1868-2012