BEUDAMED
    FDA Enforcement Class II Terminated

    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    Recall: Z-0387-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0387-2019
    Event ID
    81181
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2018
    Initiation Date
    September 26, 2018
    Classification Date
    November 3, 2018
    Termination Date
    April 13, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    Reason

    The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

    Code Info

    Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Guam. The products were distributed to the following foreign countries: Canada, United Arab Emirates and Saudi Arabia.

    Quantity

    566,737 total