BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

    Recall: Z-2281-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2281-2025
    Event ID
    97259
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefree Surgical Specialties
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    July 1, 2025
    Classification Date
    August 8, 2025
    Address
    1123 12th Avenue, Suite 341, Nampa, ID, 83686, United States

    Description

    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

    Reason

    Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

    Code Info

    Lot Code: Lot Number: 1595 UDI Code: Not Available

    Distribution

    US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.

    Quantity

    20