McKesson 419-64050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10612479272160), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

17 other recalls cover devices cleared under the same FDA submission (K030888); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Disintegration; Mechanical Problem

  THE REPORTED PRODUCT INVOLVES ONE CUSTOMER EVA 2-PORT BAG, 500 ML (64050-A8834). THE CUSTOMER REPORTED THAT A HEALTHCARE PROVIDER (PHARMACIST) OBSERVED A CIRCULAR-SHAPED PARTICULATE AFTER FILLING THE BAG DURING ROUTINE VALIDATION AND INSPECTION FOR PARTICULATES. NO PRODUCT SAMPLES WERE AVAILABLE FOR EVALUATION; HOWEVER, PHOTOGRAPHS WERE PROVIDED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR ADVERSE EVENTS.THE REPORTED PRODUCT INVOLVES ONE CUSTOMER EVA 2-PORT BAG, 500 ML (64050-A8834). THE CUSTOMER REPORTED THAT A HEALTHCARE PROVIDER (PHARMACIST) OBSERVED A CIRCULAR-SHAPED PARTICULATE AFTER FILLING THE BAG DURING ROUTINE VALIDATION AND INSPECTION FOR PARTICULATES. NO PRODUCT SAMPLES WERE AVAILABLE FOR EVALUATION; HOWEVER, PHOTOGRAPHS WERE PROVIDED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402704 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030888. One submission often covers many models, so check the product and lot details in each record.

• Z-0338-2025 · Oct 9, 2024 · 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-0344-2025 · Oct 9, 2024 · 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 · Oct 9, 2024 · 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.
• Z-0340-2025 · Oct 9, 2024 · 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-0339-2025 · Oct 9, 2024 · 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-0342-2025 · Oct 9, 2024 · 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-0341-2025 · Oct 9, 2024 · Open, Classified
  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.
• Z-0335-2025 · Oct 9, 2024 · 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-0343-2025 · Oct 9, 2024 · 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-0330-2025 · Oct 9, 2024 · 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-0332-2025 · Oct 9, 2024 · 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-0336-2025 · Oct 9, 2024 · 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-0333-2025 · Oct 9, 2024 · 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-0337-2025 · Oct 9, 2024 · 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-0331-2025 · Oct 9, 2024 · 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.

…and 2 more.