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Class 2 Device Recall Smiths Medical |
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Date Initiated by Firm |
March 17, 2014 |
Date Posted |
April 09, 2014 |
Recall Status1 |
Terminated 3 on June 09, 2015 |
Recall Number |
Z-1444-2014 |
Recall Event ID |
67714 |
510(K)Number |
K911383
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Product Classification |
Warmer, thermal, infusion fluid - Product Code LGZ
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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 MA 02370-1136
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For Additional Information Contact |
781-878-8011
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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
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LGZ and Original Applicant = LEVEL 1 TECHNOLOGIES, INC.
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