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The Metrix Company

Country not established FDA establishment FEI 1000117446

Devices
1
Registrations
FDA
FDA recalls
3316 ongoing
8 open since before 2021

Catalogue1

Newest first, rows 1-1 of 1

  • Metrixcare Ref K132424

    Class II
    Active 510(k) 510(k) II

Company details

FDA FEI number
1000117446
Address
4400 Chavenelle Rd, DUBUQUE, IA, 52002

FDA recalls33

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 1
  • 2018 8
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 16
  • 2025 0
  • 2026 0

8 initiated before 2017

Showing the 10 most recent of 33 recalls.

  • 2024

    • 9 Oct 2024 Z-0330-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0331-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0332-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0333-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0334-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0335-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0336-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0337-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0338-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0339-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
Show the 25 most recent of 33 recalls
  • 2024

    • 9 Oct 2024 Z-0340-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0341-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0342-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0343-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0344-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
    • 9 Oct 2024 Z-0345-2025 Class II Ongoing A limited number of IV bags have been found to leak during filling. Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
      Submission number: K030888
  • 2018

    • 21 Sep 2018 Z-0001-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0002-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0003-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0004-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0005-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0006-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0007-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
    • 21 Sep 2018 Z-0008-2020 Class II Open since 2018 Potential for leaking product Distribution: US Nationwide distribution including the states of PA, MA, IL CA. Submission number: K960581
  • 2017

    • 13 Sep 2017 Z-3240-2017 Class II Terminated 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. Distribution: AZ, MA, IL, FL Submission number: K843523

Frequently asked questions

How many devices does THE METRIX COMPANY have in the registry?

The registry currently lists 1 device for THE METRIX COMPANY. Devices recorded under merged duplicate company entries are counted once.

Which registries list THE METRIX COMPANY's devices?

Among its 1 most recently registered device, THE METRIX COMPANY has devices listed in FDA 510(k) (1 device).

What risk classes do THE METRIX COMPANY's devices fall under?

Among its 1 most recently registered device, the classes recorded for THE METRIX COMPANY's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for THE METRIX COMPANY?

FDA recall records list 33 recalls initiated by THE METRIX COMPANY, the most recent initiated on 2024-10-09. 24 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from THE METRIX COMPANY in the registry?

The most recently registered devices listed for THE METRIX COMPANY include METRIXCARE.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.