BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1444-2013 · Initiated June 1, 2012

    Recall

    Recall Number
    Z-1444-2013
    Event Number
    64826
    Firm
    I-Flow LLC
    FEI Number
    3011270181
    Product Code
    BSO
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    June 1, 2012
    Posted
    June 3, 2013
    Terminated
    June 25, 2013
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.

    Quantity

    450 units