HIgH-Flo™ Needle Set RMS42412Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00659443000674), received between Oct 24, 2024 and Oct 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K122404, K200176, K211206, K214045, K252015); 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.

• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. ADDITIONAL INFORMATION WAS PROVIDED FOR NURSE#1 STATING THE NEEDLE STICK OCCURRED DUE TO THE PATIENT NOT CLOSING THEM CORRECTLY AND WHILE THE NURSE WAS DISPOSING THEM IN THE SHARPS CONTAINER, THE NURSE'S LEFT POINTER FINGER WAS PUNCTURED. THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENT OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYING INFORMATION FOR THE NURSE DUE TO CONFIDENTIALITY. A LOT NUMBER FOR THE NEEDLE SET WAS NOT PROVIDED HOWEVER THE SET USED WAS A KORU HIGH-FLO 24 GAUGE NEEDLE SET - 4 NEEDLES - 12 MM. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20527407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122404, K200176, K211206, K214045, K252015. One submission often covers many models, so check the product and lot details in each record.

• Z-0051-2020 · Aug 20, 2019 · Terminated
  20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery
• Z-0318-2018 · Mar 10, 2016 · Terminated
  HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS1