BEUDAMED
    FDA Recall Terminated

    Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension St with luer activated device with silver for IV Access and Male Luer Lock Adapter, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 6N8222

    Recall: Z-0352-2011 · Initiated September 17, 2010

    Recall

    Recall Number
    Z-0352-2011
    Event Number
    56792
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    LBJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 17, 2010
    Posted
    November 15, 2010
    Terminated
    October 4, 2011
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.5 mL, 1 Catheter Extension St with luer activated device with silver for IV Access and Male Luer Lock Adapter, 1 VITAL-HOLD medium catheter stabilization device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 6N8222

    Reason

    The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. The device is labeled as nonpyrogenic.

    Action

    Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.

    Distribution

    Nationwide Distribution: Throughout the US.

    Quantity

    1,000 units