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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description Smiths Medical HOTLINEĀ® Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Recall Number Z-1444-2014
Classification Class II
Code Info 2513261 2531612 2540540 2545044 2588656
Product Distributed Qty 870 units
Reason For Recall Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

Event Detail

Event Id 67714
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 2014-03-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.