BEUDAMED
    FDA Enforcement Class II Ongoing

    PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US

    Recall: Z-0668-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0668-2024
    Event ID
    93503
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    December 6, 2023
    Classification Date
    January 5, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US

    Reason

    Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

    Code Info

    a) SPG1016: UDI/DI 85412818429, b) SPG0404: UDI/DI 85412818672, c) SPG0608: UDI/DI 85412818313, d) SPG0814: UDI/DI 85412818375, e) PC1016SNBIO: UDI/DI 85412530710, f) PC0404SNBIO: UDI/DI 85412530642, g) PC0608SNBIO: UDI/DI 85412530673, h) PC0814SNBIO: UDI/DI 85412530697, All serial numbers

    Distribution

    US Nationwide distribution.