BEUDAMED
    FDA Recall Open, Classified

    Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B

    Recall: Z-1157-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-1157-2023
    Event Number
    91560
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    LRS
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 18, 2022
    Posted
    February 22, 2023
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B

    Reason

    Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

    Action

    Cardinal Health issued Urgent: Product Correction letter and Acknowledgement Form was sent overnight on November 18, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: [email protected] For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits please notify your customers of this recall. We sincerely apologize for any inconvenience this notice may have caused you and your staff. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332

    Distribution

    US Nationwide distribution in the states of GA, PA.

    Quantity

    4560 EA