RMS Precision Flow Rate TubingTM F275Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00659443000162), received between May 2, 2019 and May 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

1 other recall cover devices cleared under the same FDA submission (K933652); 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 18, 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.

• MalfunctionMay 2, 2019Excess Flow or Over-Infusion

  DURING INFUSION OF HIZENTRA PATIENTED EXPERIENED A FAST INFUSION, NEARLY HALF THE TIME AS THE PREVIOUS THREE INFUSIONS WITH THE SAME PRODUCT. NURSE VERIFIED THAT ALL SUPPLIES ARE CORRECT. WITHIN 5 HOURS OF INFUSION PATIENT EXPERIENECED DIARRHEA, NAUSEA, DIZZINESS AND WAS DIAPHORETIC. PATIENT WAS MANAGED AT HOME AND IS DOING BETTER.

  Patient problems: Diaphoresis; Diarrhea; Dizziness; Nausea

  MAUDE report 8575318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933652. One submission often covers many models, so check the product and lot details in each record.

• Z-0317-2018 · Mar 10, 2016 · Terminated
  Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.