SECURE recallZ-0341-2025 · The Metrix Company · initiated Oct 9, 2024

Why it was recalled

A limited number of IV bags have been found to leak during filling.

FDA root cause category: Under Investigation by firm

What the company is doing

The Metrix Company issued an URGENT: NOTICE OFMEDICAL DEVICE RECALL notice to it consignees on 10/09/2024 via email. The notice explained the issue and requested destruction of all affected product. Distributors were directed to notify their customers. For questions, contact: Demitrianna Soppe, Regulatory Affairs Specialist, The Metrix Company, 4400 Chavenelle Road, Dubuque, IA 52002; Telephone: 563-556-8800; E-mail: [email protected]

Recall details

Recall number

Z-0341-2025

Status

Open, Classified

Initiated by the company

Oct 9, 2024

Posted by the FDA

Nov 8, 2024

Recalling firm

The Metrix Company

Quantity

277 cases of 50 units

Product code

KPE

FDA submissions

K030888

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 country of Canada.

Product description

SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• SECURE® 66055

  Metrix Company, The · Container, I.V.
  1 recall0 reports

Product lines

• SECUREMetrix Company, The · 16 models · 43 reports · 8 recalls

Other devices under the same FDA submission

24 devices cleared under K030888 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• SECURE® 66040

  Metrix Company, The · Container, I.V.
  1 recall8 reports
• SECURE® 66045

  Metrix Company, The · Container, I.V.
  1 recall7 reports
• SECURE® 66043

  Metrix Company, The · Container, I.V.
  1 recall3 reports
• SECURE® 66041

  Metrix Company, The · Container, I.V.
  1 recall2 reports
• CORMIX MS64045

  Metrix Company, The · Container, I.V.
  1 recall1 report
• NA 68040

  Metrix Company, The · Container, I.V.
  1 recall1 report
• SECURE® 66050

  Metrix Company, The · Container, I.V.
  1 recall1 report
• NA CMS-9601

  Metrix Company, The · Container, I.V.
  1 recall0 reports
• NA CMS-9602

  Metrix Company, The · Container, I.V.
  1 recall0 reports
• CORMIX MS64040

  Metrix Company, The · Container, I.V.
  1 recall0 reports
• CORMIX MS64050

  Metrix Company, The · Container, I.V.
  1 recall0 reports
• NA 68045

  Metrix Company, The · Container, I.V.
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95499).

• Z-0330-2025 · Open, Classified
  VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0331-2025 · Open, Classified
  VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0332-2025 · Open, Classified
  CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0333-2025 · Open, Classified
  CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0334-2025 · Open, Classified
  CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0335-2025 · Open, Classified
  SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0336-2025 · Open, Classified
  SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0337-2025 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0338-2025 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0339-2025 · Open, Classified
  SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0340-2025 · Open, Classified
  SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0342-2025 · Open, Classified
  Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0343-2025 · Open, Classified
  Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0344-2025 · Open, Classified
  Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0345-2025 · Open, Classified
  Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.