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Class 2 Device Recall SmartInfuser Pain Pump |
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Date Initiated by Firm |
January 08, 2009 |
Date Posted |
March 08, 2010 |
Recall Status1 |
Terminated 3 on April 25, 2011 |
Recall Number |
Z-1021-2010 |
Recall Event ID |
54089 |
510(K)Number |
K061409
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Product Classification |
Pain Pump - Product Code MEB
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Product |
SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. |
Code Information |
All models and all lot codes in the USA received 1/1/2007 through 1/22/2009. |
Recalling Firm/ Manufacturer |
Hsmg, Inc. D/b/a Smartinfuser Usa 8588 Katy Freeway Suite 348 Houston TX 77024
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Manufacturer Reason for Recall |
Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
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FDA Determined Cause 2 |
Process control |
Action |
SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009. |
Quantity in Commerce |
6,393 units |
Distribution |
Nationwide. |
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 = MEB and Original Applicant = PRECISE MEDICAL PRODUCTS, LTD.
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