BEUDAMED
    FDA Enforcement Class II Ongoing

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor

    Recall: Z-0929-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0929-2025
    Event ID
    95946
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sklar Instruments
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 3, 2024
    Classification Date
    January 16, 2025
    Address
    1333 Lenape Rd, West Chester, PA, 19382-6816, United States

    Description

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor

    Reason

    Reports of various packaging issues that may result in a breach of the sterile barrier.

    Code Info

    1) 96-2201A, UDI/DI 50649111493100, Lot Codes: SK-120; 2) 96-2203A, UDI/DI 50649111493094, Lot Codes: SK-120; 3) 96-2207A, UDI/DI 50649111493117, Lot Codes: SK-120; 4) 96-2208A, UDI/DI 50649111493124, Lot Codes: SK-120 5) 96-2209A, UDI/DI 50649111493155, Lot Codes: SK-120; 6) 96-2210A, UDI/DI 50649111493162, Lot Codes: SK-130; 7) 96-2241A, UDI/DI 50649111492820, Lot Codes: SK-115; 8) 96-2242A, UDI/DI 50649111492837, Lot Codes: SK-115;

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    75 units