| Class 2 Device Recall IFlow ONQ Pain Relief System | |
Date Initiated by Firm | June 01, 2012 |
Date Posted | June 03, 2013 |
Recall Status1 |
Terminated 3 on June 25, 2013 |
Recall Number | Z-1445-2013 |
Recall Event ID |
64826 |
510(K)Number | K904440 |
Product Classification |
Catheter, conduction, anesthetic - Product Code BSO
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Product | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T
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 # AW207202U |
Recalling Firm/ Manufacturer |
I-Flow LLC 20202 Windrow Dr Lake Forest CA 92630-8152
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For Additional Information Contact | 949-206-2700 |
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 | 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 | 75 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 |
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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 = BSO
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