BEUDAMED
    FDA Enforcement Class II Ongoing

    Infant Heel Warmers w/strap, Reference # 989805603201 1223

    Recall: Z-0506-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0506-2022
    Event ID
    89163
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 26, 2022
    Initiation Date
    November 29, 2021
    Classification Date
    January 19, 2022
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Infant Heel Warmers w/strap, Reference # 989805603201 1223

    Reason

    After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

    Code Info

    All units are impacted

    Distribution

    US Nationwide and Canada.

    Quantity

    5,164,600 units