BEUDAMED
    FDA Enforcement Class II Ongoing

    Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

    Recall: Z-0698-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0698-2020
    Event ID
    84283
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2019
    Initiation Date
    October 30, 2019
    Classification Date
    December 18, 2019
    Address
    Three Lakes Drive, Northfield, IL, 60093, United States

    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.

    Code Info

    Product Model DYNJAPF6057A; Lots 19GBI659 and 19HBP065

    Distribution

    USA - 2 consignees in PA only

    Quantity

    4040 units