BEUDAMED
    FDA Recall Terminated

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    Recall: Z-1255-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1255-2022
    Event Number
    90199
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 3, 2022
    Terminated
    June 27, 2022
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    Reason

    Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.

    Action

    ROI notified the sole consignee with a MEDICAL DEVICE RECALL NOTICE by email on 05/03/2022. The letter explained the problem and requested the following actions: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the item/lot number listed in the above table are in your inventory. 2. HOLD: Quarantine all affected kits in your inventory and do not further distribute or use. 3. REPLY: Complete the recall reply form attached to this notice and return to [email protected]. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. 4. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this recall notice. You may include a copy of this notice as well as the notice issued by Medline to supplement your communication.

    Distribution

    FL

    Quantity

    24 kits