RMS Precision Flow Rate TubingTM F2400Recalls & reported problems
Repro Med Systems, Inc. · Flow Control Infusion Tubing · 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 00659443000223), received between Dec 5, 2022 and Dec 5, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K933652); 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 18, 2026.
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.
MalfunctionDec 5, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON (B)(6) 2022, KORU MEDICAL WAS MADE AWARE OF A REPORT RECEIVED FROM A CLINICAL SITE IN (B)(6) STATING "SOMETHING BLACK WAS INSIDE A PACK OF TUBE. IT IS A FOREIGN SUBSTANCE. THE PACK OF TUBE WAS QUARANTINED NOT TO BE DISPENSED TO PATIENTS." A PICTURE OF THE POUCH WAS INCLUDED WITH THE REPORT CONFIRMING FOREIGN MATTER INSIDE THE POUCH. THE AFFECTED LOT IS PRECISION FLOW RATE TUBING SET F2400/LOT T.80388. A RETURN MATERIAL AUTHORIZATION WAS CREATED FOR RETURN OF THE POUCH TO KORU MEDICAL FOR FURTHER EVALUATION. THE PRODUCT IS PENDING RETURN TO KORU MEDICAL AT THIS TIME. AN INTERNAL QUALITY ALERT WAS ISSUED BY KORU MEDICAL TO NOTIFY APPROPRIATE DEPARTMENTS OF THE COMPLAINT. 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 15916320 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K933652. One submission often covers many models, so check the product and lot details in each record.
- Z-0317-2018 · Mar 10, 2016 · TerminatedFreedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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