BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

    Recall: Z-1380-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1380-2024
    Event ID
    94152
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2024
    Initiation Date
    February 28, 2024
    Classification Date
    March 26, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

    Reason

    A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.

    Code Info

    a) SPG0404, UDI/DI 00085412818672; b) SPG0406, UDI/DI 00085412818696; c) SPG0608, UDI/DI 00085412818313; d) SPG0814, UDI/DI 00085412818375; e) SPG1016, UDI/DI 00085412818429; ALL LOTS WITHIN EXPIRY

    Distribution

    US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    4774 units