CLEARLINK/BURETROL 3C0157Recalls & reported problems
Baxter International Inc. · BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Large Bore Stopcock with Rotating Male Luer Lock Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412073415), received between Mar 19, 2020 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K123874); 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
- Device Contamination with Chemical or Other Material1
- Free or Unrestricted Flow1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Free or Unrestricted Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952227 ↗MalfunctionApr 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM BURETROL SOLUTION SETS WERE FOUND WITH A PIECE OF DEBRIS IN THE NEEDLE THAT ALLOWS FLUID FLOW FROM THE DRIP (BURETTE) CHAMBER INTO THE SQUEEZE (DRIP) CHAMBER. THIS WAS IDENTIFIED WHEN CHECKING THE DEVICES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16808731 ↗MalfunctionMar 19, 2020Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A CLEALINK SYSTEM BURETROL SOLUTION SET APPEARED TAMPERED WITH. THE CONTENTS OF THE BOX WERE REPACKAGED IN A DIFFERENT BOX AND THE LABEL WAS ALSO MOVED TO THE NEW BOX. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9856296 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123874. One submission often covers many models, so check the product and lot details in each record.
- Z-2613-2014 · Jul 14, 2014 · Terminated***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is S
- Z-2615-2014 · Jul 14, 2014 · Terminated***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***F
- Z-2614-2014 · Jul 14, 2014 · Terminated***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid pat
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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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