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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62556
Product Type Devices
Status Ongoing
Recalling Firm FMS, Finapres Medical Systems BV
City Amsterdam
Country NL
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution - including the states of: OH and NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. Serial Numbers: 12 02 006, 12 02 008, 12 02 013 Class II Battery may become hot and leak 3 units US Z-2150-2012