HIgH-Flo™ Needle Set RMS22409Recalls & reported problems
Repro Med Systems, Inc. · 24 Gauge Needle Sets - 2 needles - 9 mm · Class 2
All models of HIgH-Flo Needle Set (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00659443000582), received between Apr 20, 2026 and Apr 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
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.
MalfunctionApr 20, 2026Contamination
KORU MEDICAL BECAME AWARE THAT, DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS OR CONTAMINATION WAS FOUND INSIDE EIGHT SEALED HIGH-FLO NEEDLE SET POUCHES AND ONE SEALED PRECISION FLOW RATE TUBING POUCH. ADDITIONALLY, TWO POUCHES FROM HIGH-FLO NEEDLE SET RMS12414/LOT N.86873 WERE FOUND TO BE DAMAGED, POTENTIALLY COMPROMISING THE STERILE BARRIER. MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED FOR EACH AFFECTED DEVICE MALFUNCTION AND LOT. MDR IS BEING FILED DUE TO CONTAMINATION OF FOUR POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22409/LOT N.25D32N. MDR 1318360-2026-00010 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/LOT N.86873. MDR 1318360-2026-00011 IS BEING FILED DUE TO DELIVERY OF (POTENTIALLY) UNSTERILE PRODUCTS OF TWO POUCHES ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS12414/N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/N.86872. MDR 1318360-2026-00013 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE TO CONTAMINA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928041 ↗
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 · Terminated20" 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 · TerminatedHIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS1
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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