CLEARLINK/CONTINU-FLO 2C6256Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00085412073682), received between Apr 24, 2019 and Oct 31, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K130245); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AND HAD CONNECTION ISSUES WITH THE STOPCOCK. THE CONNECTION POINTS HAVE TO BE TIGHTENED AND ADJUSTED PRIOR TO USE AND DURING USE TO ENSURE THERE IS NO DISRUPTION IN THE SET. THIS WAS OBSERVED DURING USE. 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 23442684 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK CONTINU-FLO SOLUTION SETS WERE HAVING LEAKING/CONNECTION ISSUES. THESE ISSUES WERE OBSERVED IN THE POST-ANESTHESIA CARE UNIT (PACU). 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 23442313 ↗
• MalfunctionSep 4, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT SEVENTEEN (17) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD DAMAGED PACKAGING. THE ISSUE WAS FURTHER DESCRIBED AS, THE SETS HAD "RIPPLED CLEAR PACKAGING", WITH NO VISIBLE DAMAGE TO THE BOXES OR TEARS IN THE PACKAGING. THE PLASTIC WRAP SEEMS TO HAVE BEEN EXPOSED TO HEAT, WHICH MAY HAVE CAUSED IT TO MELT. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963588 ↗
• MalfunctionSep 4, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THREE (03) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD DAMAGED PACKAGING. THE ISSUE WAS FURTHER DESCRIBED AS, THE SETS HAD "RIPPLED CLEAR PACKAGING", WITH NO VISIBLE DAMAGE TO THE BOXES OR TEARS IN THE PACKAGING. THE PLASTIC WRAP SEEMS TO HAVE BEEN EXPOSED TO HEAT, WHICH MAY HAVE CAUSED IT TO MELT. THIS WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963584 ↗
• MalfunctionJan 14, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD A MALFORMATION AT THE LUER COLLAR THAT SCREWED ONTO THE EXTENSION SET AND BROKE. THE PROCESS STEP WAS NOT SPECIFIED. 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 21151913 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT THE STOPCOCKS OF FOUR (4) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS BROKE. THIS OCCURRED DURING NORMAL USE OF THE DEVICE. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED DURING 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 20641928 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE MANIFOLD OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET USED FOR ANESTHESIA SNAPPED IN HALF WHICH RESULTED IN A LEAK. INTRAVENOUS FLUID SATURATED A PATIENT WHILE AWAITING SURGERY. THE PATIENT'S GOWN AND BED WERE FOUND WET WITH LACTATED RINGER'S SOLUTION WHICH REQUIRED A LINEN CHANGE. THE SET AND BAG OF INTRAVENOUS SOLUTION WERE CHANGED. 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 18792268 ↗
• MalfunctionJul 20, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS "UNHOOKED" OUT OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367693 ↗
• MalfunctionJul 19, 2023Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS DISCONNECTED AT THE CONNECTION SITES AND HAD A TUBING BREAK. THESE ISSUES OCCURRED DURING A PROCEDURE AND WHILE IN USE IN THE HOSPITAL. 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 17351695 ↗
• MalfunctionAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING WHERE THE SET CONNECTS TO THE PATIENT. THIS WAS OBSERVED DURING PATIENT INFUSION WITH UNSPECIFIED FLUID. 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 12360355 ↗
• MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING WHERE IT IS CONNECTED TO THE PATIENT. THIS WAS OBSERVED DURING PATIENT INFUSION WITH UNSPECIFIED FLUID. IT WAS STATED THE PATIENT WAS IN DIRECT CONTACT WITH THE LEAKED FLUID, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324522 ↗
• MalfunctionJul 23, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION JOINT IN THE THREE POINT MANIFOLD OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET IS BREAKING OFF WHICH RESULTED IN A LEAK. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS LODGED IN THE TUBING. THE ISSUE WAS IDENTIFIED DURING ELECTROCONVULSIVE THERAPY (ECT) AFTER UNSPECIFIED MEDICATION HAD BEEN "PUSHED THROUGH" THE SET. THE SET HAD TO BE REPLACED. 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 12220909 ↗
• MalfunctionApr 15, 2021Disconnection; Disconnection

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS SEPARATED. IT WAS FURTHER REPORTED "THE TUBING WAS COMING LOOSE ON EITHER SIDE OF THE STOPCOCKS". THE EVENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671697 ↗
• MalfunctionOct 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE THREE-PORT UNIT OF AT LEAST TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE NOT TIGHTLY SCREWED INTO THE TUBING; IT WOULD COME LOOSE. IT WAS FURTHER REPORTED THAT THE THREE-PORT COMPONENT WAS LIGHTLY ATTACHED. THIS ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10631916 ↗
• MalfunctionMar 11, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTION OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET ¿COMPLETELY CAME APART¿. THIS ISSUE WAS IDENTIFIED WHEN IT WAS BEING SET UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819104 ↗
• MalfunctionAug 6, 2019No Flow; No Flow

  IT WAS REPORTED ONE CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WOULD NOT FLOW. IT WAS FURTHER SPECIFIED THAT THE SET WAS CONNECTED TO AN UNSPECIFIED BAXTER EXTENSION SET. THE EXTENSION SET WAS CHANGED THREE (3) TIMES AND STILL WOULD NOT FLOW. THIS ISSUE WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8867894 ↗
• MalfunctionApr 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT SEVEN (7) CLEARLINK CONTINU-FLO SOLUTION SETS LEAKED "NEAR THE CAP''. THIS OCCURRED DURING INFUSION. THE EVENTS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547295 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2026 · Aug 29, 2025 · Open, Classified
  CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code