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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64013
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Company
City Franklin Lakes
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing. Reference No.: 367960; Tube Size: 13 X 75. Reference Nos. 367961-367963, and 368035; Tube Size: 13 X 100; all lots Class III BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints. 225 million units Z-0911-2013