CLEARLINK/BURETROL 2R8864Recalls & reported problems
Baxter Healthcare Corporation · Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar · Class 2
All models of CLEARLINK/BURETROL (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412565705), received between Jun 4, 2024 and Aug 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
- Fluid/Blood Leak1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2024No Flow; No Flow
IT WAS REPORTED THAT THERE WAS NO FLUID FLOW THROUGH AN UNSPECIFIED QUANTITY (AT LEAST FIVE) CLEARLINK BURETROL SOLUTION SETS. IT WAS OBSERVED THAT THE IV (INTRAVENOUS) SOLUTION STOPS FLOWING WITHIN A FEW MINUTES AFTER FLUSHING. THE STOPPER WAS NOT COMPRESSING OR CAUSING THE FLOW TO STOP. THE IV SOLUTION STARTS TO BACK UP, REQUIRING A SECOND FLUSH TO CONTINUE FUNCTIONING. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THIS EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972890 ↗MalfunctionJun 4, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK BURETROL SOLUTION SETS LEAKED. THE SPIKE WOULD DISCONNECT FROM THE IV (INTRAVENOUS) BAG FROM A SMALL TUG OR MOVEMENT CAUSING MEDICATED SOLUTION (MAGNESIUM SOLUTION) TO ¿RUN OUT RAPIDLY TO THE FLOOR OR ON THE NURSES.¿ THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460521 ↗
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-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
- 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
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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.
How reports and recalls are matched · Editorial policy · Report an error on this page