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
|