BEUDAMED
    FDA Enforcement Class II Ongoing

    Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

    Recall: Z-2790-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2790-2018
    Event ID
    80519
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Guangzhou Improve Medical Instruments Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 22, 2018
    Initiation Date
    October 19, 2016
    Classification Date
    August 11, 2018
    Address
    NO. 102 Kaiyuan Avenue, Science City, Guangzhou, N/A, China

    Description

    Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

    Reason

    Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.

    Code Info

    Serial Number 102030132 Lots #'s: 20150210 and 20150410

    Distribution

    Puerto Rico

    Quantity

    700,000