HIgH-Flo™ Needle Set RMS32614Recalls & reported problems
Repro Med Systems, Inc. · 26 Gauge Needle Sets - 3 needles - 14 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 00659443000377), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
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.
MalfunctionFeb 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON 28-JAN-2025 KORU MEDICAL RECEIVED 30 NEEDLE SETS (3 BOXES) OF RMS32614 (HIGH-FLO NEEDLE SET 26 GAUGE NEEDLE SETS - 3 NEEDLES - 14 MM) LOT N.86417 FROM A CUSTOMER UNDER A RETURN MATERIAL AUTHORIZATION. THERE WAS NO PATIENT INVOLVEMENT. DURING QUALITY CONTROL INSPECTION OF THE 30 NEEDLE SETS PERFORMED ON 29-JAN-2025, 2 NEEDLE SETS WERE FOUND CONTAMINATED WITH BLACK DEBRIS AND WHAT APPEARED TO BE HAIR. KORU INITIATED AN INTERNAL NON-CONFORMANCE REPORT TO INVESTIGATE. IN ADDITION, AN INTERNAL QUALITY ALERT WAS INITIATED TO INFORM INTERNAL PERSONNEL OF THE NON-CONFORMANCE. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458437 ↗
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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