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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINEĀ® 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINEĀ® 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
Recall Number Z-1979-2012
Classification Class II
Code Info All serial numbers
Product Distributed Qty 2247 units
Reason For Recall HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

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