Enforcement Report - Week of July 18, 2012
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Event Detail
| Event ID | 62389 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Smiths Medical ASD, Inc. |
| City | Rockland |
| State | MA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE® 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE® 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments | All serial numbers | Class II | HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable | 2247 units | Z-1979-2012 |
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