Blood Administration Set V2500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964188633), received between Apr 4, 2019 and Sep 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 20, 2019Terminated

   Potential for leakage at the joint between the blood filters and tubing

   Z-0941-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: ACCORDING TO THE REPORT, THERE WAS A HAIR INSIDE THE TUBING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419047 ↗
• MalfunctionApr 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS A DARK OBJECT NOTED INSIDE THE BLOOD FILTER. CUSTOMER STATES THAT THE FOREIGN OBJECT LOOKS LIKE THE BODY AND WINGS OF AN INSECT. NO INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8484483 ↗