HIgH-Flo™ Needle Set RMS12409Recalls & reported problems
Repro Med Systems, Inc. · 24 Gauge Needle Sets - 1 needle - 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 00659443000544), received between Jul 6, 2026 and Jul 6, 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.
MalfunctionJul 6, 2026Contamination
KORU MEDICAL BECAME AWARE OF A REPORT FROM A CUSTOMER ON 09-JUN-2026 STATING "ONE (1) UNIT OF RMS12409 (LOT N.25J38N) HAS BEEN OBSERVED WITH VISUAL DEFECT/POSSIBLE CONTAMINANT ON THE TUBING." ON 09-JUN-2026, KORU QUALITY CONTROL PULLED ALL REMAINING INVENTORY ON THIS LOT (14 POUCHES) WHICH WERE VISUALLY INSPECTED, AND DEBRIS WAS FOUND IN 3 OF THE POUCHES. THE CUSTOMER PROVIDED PHOTOS OF THE POUCH CONFIRMING THE COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT. A RETURN MATERIAL AUTHORIZATION WAS CREATED TO RETURN THE AFFECTED POUCH TO KORU MEDICAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR HIGH-FLO NEEDLE SET RMS12409/LOT N.25J38N WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. IN ADDITION, HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHODS. THE INSTRUCTIONS FOR USE FOR THE HIGH-FLO NEEDLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25717674 ↗
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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