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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64848
Product Type Devices
Status Ongoing
Recalling Firm Heritage Labs International LLC
City Olathe
State KS
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients. Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013 Class II The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results. 25 kits Z-1131-2013