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N/A IN900012Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Vital Signs Pressure Infusor Bag, 1000 mL · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327500110), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pressure Problem” (1 report).

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.

Most reported problems

Device problems

  • Pressure Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 23, 2021Pressure Problem; Pressure Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT IN900012 INFUSO PRESSURE (SERUM RUSH) 1000 ML LOSE PRESSURE DURING THE OPERATION OF THE DEVICE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11368837 ↗

Other INFUSOR, PRESSURE, FOR I.V. BAGS devices

All INFUSOR, PRESSURE, FOR I.V. BAGS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.