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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical

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 Class 2 Recall
Smiths Medical
see related information
Date Posted April 09, 2014
Recall Status1 Open
Recall Number Z-1444-2014
Recall Event ID 67714
Premarket Notification
510(K) Number
K911383 
Product Classification Warmer, Thermal, Infusion Fluid - Product Code LGZ
Product Smiths Medical HOTLINE® Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Code Information 2513261 2531612 2540540 2545044 2588656
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
160 Weymouth St
Rockland, Massachusetts 02370-1136
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail Shirley.duggan@smiths-medical.com.
Quantity in Commerce 870 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LGZ and Original Applicant = LEVEL 1 TECHNOLOGIES, INC.
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