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U.S. Department of Health and Human Services

Class 2 Device Recall SmartBlock

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  Class 2 Device Recall SmartBlock see related information
Date Initiated by Firm January 08, 2009
Date Posted March 08, 2010
Recall Status1 Terminated 3 on April 25, 2011
Recall Number Z-1022-2010
Recall Event ID 54089
510(K)Number K072053  
Product Classification Pain Pump - Product Code MEB
Product SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
Code Information All models and lot codes received 1/1/2007 to 1/22/2009. Part numbers P49524, P49534, P49624, and P49634.
Recalling Firm/
Manufacturer		 Hsmg, Inc. D/b/a Smartinfuser Usa
8588 Katy Freeway Suite 348
Houston TX 77024
Manufacturer Reason
for Recall		 Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
FDA Determined
Cause 2		 Process control
Action SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
Quantity in Commerce 444 units
Distribution Nationwide.
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 = MEB and Original Applicant = MEDICAL FLOW SYSTEMS LTD
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