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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical

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  Class 2 Device Recall Smiths Medical see related information
Date Initiated by Firm March 17, 2014
Date Posted April 09, 2014
Recall Status1 Terminated 3 on June 09, 2015
Recall Number Z-1443-2014
Recall Event ID 67714
510(K)Number K911383  
Product Classification Warmer, thermal, infusion fluid - Product Code LGZ
Product Smiths Medical HOTLINE¿ Fluid Warming Set L-70.

Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Code Information 2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information Contact
781-878-8011
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		 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 393,210
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 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.
510(K) Database 510(K)s with Product Code = LGZ and Original Applicant = LEVEL 1 TECHNOLOGIES, INC.
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