BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.

    Recall: Z-1080-2016 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1080-2016
    Event ID
    72961
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Value Plastics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 16, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    March 9, 2016
    Termination Date
    August 17, 2016
    Address
    3325 S Timberline Rd, N/A, Fort Collins, CO, 80525-2903, United States

    Description

    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.

    Reason

    Potential for the parts to crack.

    Code Info

    Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015

    Distribution

    3 Consignees in NY, PA, MN. No foreign, VA/govt.

    Quantity

    33,000