BEUDAMED
    FDA Recall Terminated

    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

    Recall: Z-1716-2020 · Initiated January 7, 2020

    Recall

    Recall Number
    Z-1716-2020
    Event Number
    84681
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 7, 2020
    Posted
    April 15, 2020
    Terminated
    December 14, 2020
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

    Reason

    Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

    Action

    The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to [email protected]. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email [email protected] and phone number of 8669188738 for assistance.

    Distribution

    USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

    Quantity

    127,700 total devices