Events

Recall of SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Metrix Company.

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
    78117
  • Event Risk Class
    Class 2
  • Event Number
    Z-3240-2017
  • Event Initiated Date
    2017-09-13
  • Event Date Posted
    2017-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158688
  • 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
    Container, i.V. - Product Code KPE
  • Reason
    The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. the bags are correctly made with pvc material, as ordered and as labeled on the inner and outer boxes.
  • Action
    Recall letters will be sent to each consignee (distributors) via FedEx. The letter requested the following: "The Metrix Company is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Destroy all affected products and dispose/recycle in a manner consistent with your local waste disposal authority. 4. Complete the Response form and return it to The Metrix Company according to the instructions on the form." Distributors were instructed to contact their customers about the recall. The product is to be destroyed in the field.

Device

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports
  • Model / Serial
    UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, MA, IL, FL
  • Product Description
    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
  • Manufacturer
    The Metrix Company

Manufacturer

The Metrix Company
  • Manufacturer Address
    The Metrix Company, 4400 Chavenelle Rd, Dubuque IA 52002-2655
  • Manufacturer Parent Company (2017)
    The Metrix Company
  • Source
    USFDA