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 |
| State | |
| Country | NL |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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 |
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