HIgH-Flo™, RMS Precision Flow Rate TubingTM FEXTRecalls & reported problems
Repro Med Systems, Inc. · 24" Tubing Extender · Class 2
Data updated Oct 18, 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 00659443000698), received between Apr 20, 2026 and Apr 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
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 18, 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 1318360-2026-00009 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/LOT N.86873. MDR 1318360-2026-00012 IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH HIGH-FLO NEEDLE SET RMS22414/LOT N.86872. MDR IS BEING FILED DUE TO CONTAMINATION OF ONE POUCH ASSOCIATED WITH PRECISION FLOW RATE TUBING FEXT/LOT T.87065. MDR 1318360-2026-00014 IS BEING FILED DUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932044 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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