Rate Flow® L2590263-V5922Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08436020767302), received between Oct 23, 2018 and Jun 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K851058); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ON JUNE 5TH 2023, MEDWATCH VOLUNTARY REPORT MW5117708 WAS RECEIVED FROM US IMPORTER. MEDWATCH REPORT MW5117708 STATES: RECEIVED CALL FROM PATIENT STATING THAT HER METRONIDAZOLE INFUSION IS INFUSING OVER 30 MINUTES INSTEAD OF THE 60 MINUTES IT SHOULD BE. PATIENT REPORTS THAT THE LOT FOR THE V5922 TUBING IS 221201L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180787 ↗
• MalfunctionJun 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ON MAY 12TH 2023, MEDWATCH VOLUNTARY REPORT MW5117261 WAS RECEIVED FROM US IMPORTER. MEDWATCH REPORT MW5117261 STATES: RECEIVED CALL FROM PATIENT STATING THAT HER TIGECYCLINE INFUSION IS GOING OVER 15 MINUTES AND NOT THE 30 MINUTES IT SHOULD BE. PATIENT CONFIRMED THAT SHE HAD PREVIOUSLY HAD NO ISSUE SETTING THE RATE FLOW TO 200ML/HR FOR HER 100ML INFUSION. PATIENT ATTEMPTED TO SET THE SET TO 150ML/HR BUT INFUSION IS STILL INFUSING OVER 15 MINUTES. PATIENT REPORTS THAT THE LOT FOR THE V5922 TUBING IS 221201L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078233 ↗
• MalfunctionDec 11, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  AS REPORTED BY USER FACILITY: AN INFUSION THAT SHOULD HAVE TAKEN ONE HOUR, TOOK FIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8150407 ↗
• MalfunctionOct 23, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY USER FACILITY: RATE FLOW REGULATOR RAN SIGNIFICANTLY FASTER THAN SET RATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K851058. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2011 · Mar 11, 2011 · Terminated
  "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON,