RMS Precision Flow Rate TubingTM F60Recalls & 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 00659443000131), received between Feb 18, 2025 and Feb 18, 2025 — 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.
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 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON 15-JAN-2025 KORU MEDICAL RECEIVED 6 BOXES (300 TUBING SETS) OF F60 PRECISION FLOW RATE TUBING LOT T.86467 FROM A CUSTOMER UNDER A RETURN MATERIAL AUTHORIZATION. THERE WAS NO PATIENT INVOLVEMENT. DURING QUALITY CONTROL INSPECTION OF THE 300 TUBING SETS PERFORMED ON 20-JAN-2025, 7 TUBING 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 21404237 ↗
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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