HIgH-Flo™ Needle Set RMS22609Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00659443000308), received between Apr 21, 2022 and Apr 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON (B)(6) 2022, KORU MEDICAL WAS MADE AWARE THAT DURING INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN (B)(4) AN INSECT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH. THE TEAM AT THE (B)(4) WAREHOUSE TESTED THE POUCH WITH THE DEBRIS INSIDE AND VERIFIED VIA HAND PRESSURE THAT THE BAG WAS IN FACT SEALED. SUBSEQUENTLY, THE (B)(4) WAREHOUSE CONDUCTED A 100% INSPECTION ON THE REMAINING INVENTORY FROM MODEL RMS22609/LOT N.80137. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN AN UNIDENTIFIED BLACK CONTAMINANT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED LOT N.80137 CONTAINED 1000 POUCHES. OF THE 1000, 11 POUCHES WERE PROVIDED FOR CLINICAL USE ON STUDY SUBJECTS ON (B)(6) 2022. AT THIS TIME, THE REMAINING 989 BAGS FROM THE LOT ARE QUARANTINED IN THE CUSTOMER'S INVENTORY SYSTEM. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE 2 POUCHES TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCTS ARE PENDING RETURN TO KORU MEDICAL AT THIS TIME. KORU MEDICAL COMPLETED AN INITIAL INVESTIGATION OF THE REPORTED INCIDENT. A SUMMARY OF THE RESULTS IS AS FOLLOWS: THE NEEDLE SETS WERE SHIPPED TO (B)(4) WITH THE INTENTION OF SUPPORTING A CLINICAL STUDY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166645 ↗
• MalfunctionApr 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ON 23-MAR-2022, KORU MEDICAL WAS MADE AWARE THAT DURING INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN (B)(6), JAPAN AN INSECT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH. THE TEAM AT THE JAPANESE WAREHOUSE TESTED THE POUCH WITH THE DEBRIS INSIDE AND VERIFIED VIA HAND PRESSURE THAT THE BAG WAS IN FACT SEALED. SUBSEQUENTLY, THE JAPANESE WAREHOUSE CONDUCTED A 100% INSPECTION ON THE REMAINING INVENTORY FROM MODEL RMS22609/LOT N.80137. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN AN UNIDENTIFIED BLACK CONTAMINANT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED LOT N.80137 CONTAINED 1000 POUCHES. OF THE 1000, 11 POUCHES WERE PROVIDED FOR CLINICAL USE ON STUDY SUBJECTS ON (B)(6) 2022. AT THIS TIME, THE REMAINING 989 BAGS FROM THE LOT ARE QUARANTINED IN THE CUSTOMER'S INVENTORY SYSTEM. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE 2 POUCHES TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCTS ARE PENDING RETURN TO KORU MEDICAL AT THIS TIME. KORU MEDICAL COMPLETED AN INITIAL INVESTIGATION OF THE REPORTED INCIDENT. A SUMMARY OF THE RESULTS IS AS FOLLOWS: THE NEEDLE SETS WERE SHIPPED TO JAPAN WITH THE INTENTION OF SUPPORTING A CLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166644 ↗

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