BEUDAMED
    FDA Recall Terminated

    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Recall: Z-0676-2016 · Initiated January 5, 2016

    Recall

    Recall Number
    Z-0676-2016
    Event Number
    72997
    Firm
    Rymed Technologies, LLC
    FEI Number
    3005951712
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 5, 2016
    Posted
    January 21, 2016
    Terminated
    October 19, 2016
    Address
    6000 W William Cannon Dr, Ste B300, Austin, TX, 78749-1991

    Description

    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Reason

    Potential for the female luer component of the InVision-Plus IV connector to crack during use.

    Action

    The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: [email protected], fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: [email protected] or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: [email protected] or call 512-301-7338x309.

    Distribution

    US Nationwide Distribution.

    Quantity

    46,600 units