BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

    Recall: Z-2158-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2158-2023
    Event ID
    92466
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    July 20, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

    Reason

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    Code Info

    all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038; b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974; c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470; d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631; e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512; f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730; g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119; h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173; i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096; j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691; k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668; l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646; m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340; n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817; o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928;

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

    Quantity

    23938 units