Events

Recall of 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.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Value Plastics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72961
  • Event Risk Class
    Class 2
  • Event Number
    Z-1080-2016
  • Event Initiated Date
    2015-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142593
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stopcock, i.V. Set - Product Code FMG
  • Reason
    Potential for the parts to crack.
  • Action
    Customers were initially notified by telephone call; followed by recall notice via email on 12/18/15. The recall letter instructs customers to identify their customers and notify them of the product recall. Returned product will be quarantined and separated from acceptable materials and scrapped.

Device

Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured ...
  • Model / Serial
    Catalog #: FCA026-001  Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    3 Consignees in NY, PA, MN. No foreign, VA/govt.
  • Product 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.
  • Manufacturer
    Value Plastics, Inc.

Manufacturer

Value Plastics, Inc.
  • Manufacturer Address
    Value Plastics, Inc., 3325 S Timberline Rd, Fort Collins CO 80525-2903
  • Manufacturer Parent Company (2017)
    Nordson Corporation
  • Source
    USFDA