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U.S. Department of Health and Human Services

Class 2 Device Recall IFlow ONQ Pain Relief System

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 Class 2 Recall
IFlow ONQ Pain Relief System
see related information
Date Posted June 03, 2013
Recall Status1 Terminated on June 25, 2013
Recall Number Z-1444-2013
Recall Event ID 64826
Premarket Notification
510(K) Number
K904440 
Product Classification Catheter, Conduction, Anesthetic - Product Code BSO
Product I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Code Information Lot # AW207202O
Recalling Firm/
Manufacturer
I-Flow LLC
20202 Windrow Dr
Lake Forest, California 92630-8152
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
FDA Determined
Cause 2
TRAINING: Use Error
Action IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the catheter prior to inserting it into the Stingray connector will help with connecting the catheter to the Stingray connector. Customers are instructed that there is no action required for the I Flow ON Q Pain Relief System and ON Q T Bloc. The recall letter is only to provide further instructions on successful set up of the SPIROL catheter with the Stingray Connector included in the ON-Q T-bloc trays. Customers with any questions are instructed to call IFlow Customer service at (800) 448-3569 or IFlow 24 hr Tech support at (800) 444-2728. On June 1, 2012, an I-Flow sales representative removed the catheters and connectors from the one consignee/customers. For questions regarding this recall call 949-206-2700.
Quantity in Commerce 450 units
Distribution Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSO and Original Applicant = PREFERRED MEDICAL PRODUCTS
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