BEUDAMED
    FDA Recall Open, Classified

    Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

    Recall: Z-0698-2020 · Initiated October 30, 2019

    Recall

    Recall Number
    Z-0698-2020
    Event Number
    84283
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    CAI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 30, 2019
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

    Reason

    The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.

    Action

    Consignees were notified via email by their sales representative on 11/05/2019. A letter with response form was sent via email to each consignee. Responses will be recorded and subsequent letters will be sent to those consignees that do not respond in the allotted time.

    Distribution

    USA - 2 consignees in PA only

    Quantity

    4040 units