CLEARLINK/CONTINU-FLO 2C6255Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00085412046310), received between Aug 20, 2018 and Jun 4, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0189-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CONTINU-FLO SOLUTION SETS LEAKED AT THE CONNECTOR PORT. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS DURING PATIENT INFUSION. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392221 ↗
• MalfunctionMay 12, 2026Disconnection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK CONTINU-FLO SOLUTION SETS HAD TROUBLE CONNECTING TO A NON BAXTER INTRAVENOUS (IV) CATHETER WHICH RESULTED IN DISCONNECTION AND FLUID LEAKAGE. DURING IV SETUP, IT WAS OBSERVED THAT THERE WERE REPEATED DIFFICULTIES CONNECTING SETS TO IV CATHETERS. THE LUER LOCK SPINNER ON THE SETS WOULD NOT PROPERLY THREAD ONTO THE CATHETER HUB AND APPEARED STRIPPED OR UNABLE TO SECURE A TIGHT CONNECTION. IT WAS ATTEMPTED TO CONNECT SETS FROM THREE SEPARATE PACKAGES TO AN IV CATHETER. IN EACH CASE, THE TUBING COULD NOT BE SECURED. A SYRINGE WAS ABLE TO ATTACH TO THE CATHETER WITHOUT DIFFICULTY, SUGGESTING THE ISSUE WAS ASSOCIATED WITH THE SETS RATHER THAN THE CATHETER. IN ADDITION TO THIS OCCURRENCE, THERE HAVE BEEN AT LEAST FOUR SIMILAR INSTANCES OVER THE PREVIOUS TWO WEEKS IN WHICH IV TUBING EITHER COULD NOT BE THREADED ONTO THE CATHETER OR APPEARED TO BE CONNECTED BUT SUBSEQUENTLY LEAKED. 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 25154081 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23434778 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK CONTINU-FLO SOLUTION SETS WERE LEAKING OUT OF THE PORT JUST BELOW THE ROLLER CLAMP. THE SETS HAD BEEN CONNECTED TO THE PATIENTS WHEN THE LEAKS WERE DISCOVERED. 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 22815330 ↗
• MalfunctionAug 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "PORT 9" (MALE LUER) OF AN UNSPECIFIED QUANTITY (UP TO TEN) OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WAS "LOCKED TOO TIGHTLY TO LUER ON TO THE IV CATHETER". THE ISSUE OCCURRED DURING PATIENT 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 22806838 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM "PORT 4" (CLEARLINK ABOVE THE STOPCOCK). THE ISSUE OCCURRED DURING PATIENT USE WHEN THE BAG WAS SPIKED WITH LACTATE RINGERS. 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 22806521 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Blocked Connection; Fluid/Blood Leak; Blocked Connection

  IT WAS REPORTED THAT AT LEAST TEN (10) UNITS OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, THE DEVICE LEAKED FROM THE PORT 4 (CLEARLINK) WHEN THE INTRAVENOUS TUBING WAS SPIKED WITH THE SOLUTION BAG. ADDITIONALLY, MALE LUER ADAPTER (PORT 9) WHICH CONNECTS TO THE ANGIOCATHETER, WAS FOUND TO BE LOCKED AND COULD NOT BE ATTACHED TO THE INTRAVENOUS (IV) CATHETER. IN ONE INSTANCE, THIS OCCURRED WHEN BAG WAS SPIKED WITH THE UNSPECIFIED BAG CONTAINING LACTATED RINGERS AND THE PORT 9 WAS LOCKED TOO TIGHTLY TO LUER ON TO IV CATHETER. THE TUBINGS WERE REPLACED TO RESOLVE THE ISSUE. 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 22805544 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM ONE OF THE CONNECTIONS (CLEARLINK) DURING PATIENT USE. IN SOME CASES, AN UNSPECIFIED CAP WAS PUT ON THE LEAKING CLEARLINK TO RESOLVE THE ISSUE. 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 22559661 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM THE TUBING INJECTOR SITES (CLEARLINK). THIS OCCURRED ONCE THE INTRAVENOUS THERAPY WAS STARTED. 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 20538647 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS ATTACHED WITH LARGE BORE STOPCOCK EXTENSION SETS LEAKED FROM THE CLEARLINK INJECTION SITES. THIS OCCURRED DURING USE IN PRE-OP. 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 20537135 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LARGE BORE STOPCOCK EXTENSION SET LEAKED. THE SET LEAKED BLOOD OUT OF THE STOPCOCK. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817256 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE "VALVE" (CLEARLINK) OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCESS STEP. 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 17596906 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AT THE MOST PROXIMAL VALVE, CLOSEST TO THE SOLUTION. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068097 ↗
• MalfunctionDec 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE PORTS OR LUER ACTIVATED VALVES. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 16055696 ↗
• MalfunctionDec 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM THE PORTS OR LUER ACTIVATED VALVES. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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 16051813 ↗
• MalfunctionSep 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD DEBRIS IN THE SPIKE. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS WAS IDENTIFIED. 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 15459246 ↗
• MalfunctionSep 15, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LARGE BORE STOPCOCK EXTENSION SETS DISCONNECTED AND LEAKED. THE EVENT WAS FURTHER DESCRIBED AS; ¿IV (INTRAVENOUS) TUBING COMING APART AT SOME OF THE CONNECTIONS OR SPIKES THAT ARE FALLING OUT OF THE BAG¿ RESULTING IN LEAKS. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428433 ↗
• MalfunctionSep 13, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS OBSERVED IN THE SPIKE OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS. THE ISSUE WAS IDENTIFIED DURING AN 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15411412 ↗
• MalfunctionMay 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS CRIMPED. THE ISSUE WAS IDENTIFIED DURING USE WITH ANESTHESIA. 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 11779631 ↗
• MalfunctionDec 30, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LARGE BORE STOPCOCK EXTENSION SET BECAME SEPARATED WHICH RESULTED IN LEAK OF FLUIDS. THE EVENT WAS DESCRIBED AS THE SET CAME APART AT THE STOPCOCK DURING PATIENT INFUSION. 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 11098317 ↗
• MalfunctionNov 26, 2020Backflow; Disconnection; Fluid/Blood Leak; Backflow; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SEPARATED, AND SUBSEQUENTLY LEAKED. THE EVENT WAS DESCRIBED AS THE TUBING BECAME DISCONNECTED AT THE STOPCOCK, AND, "RESULTED IN BACKFLOW OF BLOOD" WITH APPROXIMATELY 100 ML OF BLOOD LEAKED FROM THE CONNECTOR OF A CLEARLINK SET. 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 10908255 ↗
• MalfunctionNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE CONNECTION SITE. THIS WAS IDENTIFIED DURING USE. 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 10845146 ↗
• MalfunctionMar 6, 2020Disconnection; Disconnection

  IT WAS REPORTED AN UNKNOWN NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS SEPARATED. SEVERAL TIMES THE ¿TUBING HAD SEPARATED FROM THE HARD PLASTIC¿. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9799489 ↗
• MalfunctionMar 5, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN REMOVING THE BLUE CAP OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET, THE TUBING COMPLETELY SEPARATED FROM THE HARD PLASTIC. THIS WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9796002 ↗
• MalfunctionDec 17, 2019Filling Problem; Filling Problem

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET UNDER INFUSED. IT WAS FURTHER REPORTED THAT DURING A PATIENT¿S SURGICAL PROCEDURE THE TUBING KINKED; THEREFORE, ¿SLOWING THE FLUID FLOW¿. 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 9483053 ↗