BEUDAMED
    FDA Recall Open, Classified

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    Recall: Z-0315-2024 · Initiated September 21, 2023

    Recall

    Recall Number
    Z-0315-2024
    Event Number
    93204
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    OEZ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    September 21, 2023
    Posted
    November 16, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    Reason

    Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

    Action

    ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email. The email attached the notice and the notice received from Getinge. The notice explained the issue, the potential risks, and requested the distributor notify their customer. End user was directed to post the Getinge notice in area where the affect kits were used. An updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions.

    Distribution

    MO

    Quantity

    134 units