BEUDAMED
    FDA Recall Terminated

    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

    Recall: Z-1442-2020 · Initiated September 16, 2019

    Recall

    Recall Number
    Z-1442-2020
    Event Number
    84985
    Firm
    CME America, LLC
    FEI Number
    3006967710
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 16, 2019
    Posted
    March 11, 2020
    Terminated
    April 13, 2022
    Address
    14998 W 6th Ave, Ste 830, Golden, CO, 80401-5025

    Description

    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

    Reason

    When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

    Action

    Updated 10/7/2019: On 09/16/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via various methods (i.e., email, and written letter delivered by FedEx) along with a response form for customer acknowledgement. The notification informed customers, that all lots of its Microset tubing when used with their infusion pump system may under deliver fluids. The product was distributed beginning in October 2017. The firm is instructing customers to: 1. Immediately review their inventory for Catalog #A120-003XYVA and to discard all remaining inventory of the tube sets per their facility's guidelines 2. Share the Urgent Medical Device Recall notice with all users of the product with their facility to ensure awareness of this action. 3. Complete the attached Customer Response Form and return to the contact noted on the firm regardless of whether they have any affected material or not so that the Recalling Firm may acknowledge their receipt of the notification. Fax Number: 312-949-0333 or email to [email protected] are to indicate on the response form the quantity of the tube sets remaining in inventory and confirm this inventory has been discarded. 4. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. 5. Contact the Recalling Firm at 877-263-0111, Monday thru Friday from 9am to 5pm Mountain Time for a list of alternate sets that are available. Customer/Technical Support - 303-936-4545 or 877-263-0111 toll free.

    Distribution

    US: CA, OH, PA, and TX OUS: Canada

    Quantity

    69400 infusion sets