CLEARLINK/CONTINU-FLO 2C8519Recalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 00085412048994), received between Nov 21, 2017 and Sep 24, 2026 — classified as 1 death, 4 injuries, 216 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (104 reports).

3 FDA recall records name this device's identifier, 3 still open.

9 other recalls cover devices cleared under the same FDA submission (K203609, K961225); 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.

Recalls naming this device

1. Aug 29, 2025Open, Classified

   IV sets may leak.

   Z-0192-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 8, 2025Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

   Z-2594-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Dec 12, 2019Open, Classified

   Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

   Z-0793-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 221 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  During evaluation of a CLEARLINK System CONTINU-FLO Solution Set, leakage was observed due to detachment of the tubing from the clearlink during pressure testing. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878515 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134226 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED FROM THE MOST PROXIMAL Y-SITE DURING AN IRON INFUSION. THE INFUSION WAS STOPPED. 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 25568048 ↗
• MalfunctionJun 11, 2026No Flow

  IT WAS REPORTED THAT FLUID DID NOT FLOW THROUGH THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS. THE ISSUE WAS DESCRIBED AS: FLUID REACHED THE END OF THE LINE, BUT DID NOT FLOW OUT. ONCE THE CAP WAS REMOVED, THE FLUID FLOWED. THIS WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469093 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A PERFORATION WAS NOTED IN THE SEAL AT THE ACCESS LUER ACTIVATED VALVE OF A CLEARLINK SYSTEM CONTINU FLO SOLUTION SET, RESULTING IN INTRAVENOUS FLUID LEAKING FROM THE TUBING ONTO THE FLOOR. THIS OCCURRED DURING PRIMING OF THE TUBING WITH LACTATED RINGER'S SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115839 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET TUBING SEPARATED AT THE CLEARLINK Y-SITE. THE EVENT OCCURRED WHILE UNSCREWING THE LUER LOCK FROM THE IV LINE IN THE ICU. 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 25035436 ↗
• MalfunctionApr 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO (2) CONTINU-FLO SOLUTION SETS SEPARATED AT THE Y-SITE. 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 25035336 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED DURING USE OF A CLEARLINK CONTINU-FLO SOLUTION SET. THE SET WAS BEING USED WITH A BAXTER MICRON FILTER EXTENSION SET AND AN UNSPECIFIED INFUSION PUMP. TWO HOURS AFTER STARTING INFUSION, THE INFUSION PUMP ALERTED DOWNSTREAM OCCLUSION. THE TUBING WAS FOUND TO BE LEAKING FROM AN UNSPECIFIED LOCATION ONTO THE PATIENT¿S LAP. THE PATIENT WAS DISCONNECTED, THE MEDICATION BAG WAS SPIKED WITH NEW TUBING AND FILTER TUBING AND THE MEDICATION WAS RESTARTED. 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 24663065 ↗
• InjuryMar 20, 2026Audible Prompt/Feedback Problem

  IT WAS REPORTED A CLEARLINK CONTINU-FLO SOLUTION SET POTENTIALLY CAUSED A DOWNSTREAM OCCLUSION ALARM ON THE BAXTER PUMP DURING PATIENT CONTINUOUS IV INFUSION OF ESMOLOL AND HEPARIN. THE HEALTHCARE PROFESSIONAL CHECKED THE IV TUBING, FLUSHED THE PERIPHERAL IV LINE, AND ENSURED THAT NO CLAMPS OR KINKS WERE PRESENT. THE PUMP WAS RESTARTED AFTER EACH ASSESSMENT, BUT THE ALARM REOCCURRED WITHIN A FEW MINUTES. DURING THIS PERIOD, THE PATIENT BECAME TACHYCARDIC. NO ISSUES WERE NOTED WITH THE HEPARIN INFUSION, WHICH CONTINUED TO RUN WITHOUT INTERRUPTION THROUGH THE SAME IV LINE. CLINICIAN DECIDED TO REPLACE BOTH ESMOLOL INFUSION BAG, TUBING AND PUMP. ONCE DONE, THE PATIENT'S HEART RATE DECREASED BY 40 BEATS PER MINUTE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Tachycardia

  MAUDE report 24649186 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS RIPPED OR CUT WHEN IT WAS REMOVED FROM THE PACKAGING. HOWEVER, IT WAS NOT SPECIFIED IF PATIENT WAS INVOLVED. 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 24640861 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED NEAR THE PORT CLOSEST TO THE PATIENT. THIS WAS OBSERVED SHORTLY AFTER STARTING AN ANTIBIOTIC INFUSION. THE NURSE STOPPED THE INFUSION AND DISCONNECTED THE PATIENT. A NEW INFUSION WAS INITIATED TO PREVENT ANY MISSED MEDICATION DOSE. 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 24633955 ↗
• MalfunctionFeb 26, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET COULD NOT CONNECT ONTO AN IV PORT. THE COLLAR WAS UNABLE TO BE ENGAGED/MOVED. THIS WAS OBSERVED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461922 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE PORT (CLEARLINK) CLOSEST TO THE PATIENT. THE PORT WAS NOT ACCESSED AND NO SYRINGES WERE USED. THE ISSUE WAS NOTICED AFTER PATIENT INFUSION WITH MEROPENEM AND KETOROLAC AT 200ML/HR. AS AN UNSPECIFIED AMOUNT OF MEDICATION LEAKED, AN ADDITIONAL DOSE OF MEROPENEM WAS ADMINISTERED TO RESOLVE THE 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 24455369 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE OFF IN THE NON-BAXTER NEEDLELESS CONNECTOR OF THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE ISSUE WAS NOTICED WHILE ATTEMPTING TO DISCONNECT THE TUBING FOR A PATIENT. 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 24326194 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE SPIKE. THE INTRAVENOUS (IV) TUBING WAS USED TO SPIKE AN INTRAVENOUS FLUID (IVF) BAG; HOWEVER, THE FLUID IMMEDIATELY LEAKED FROM THE SPIKE AND DID NOT FLOW INTO THE TUBING. 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 24266515 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205505 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AND THE MEDICATION SPILLED. THE ISSUE WAS NOTICED PRIOR TO CONNECTING TO A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189987 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE END (MALE LUER) OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE OFF AND WAS STUCK IN A NON-BAXTER BLUE CAP (NEEDLELESS CONNECTOR). THE ISSUE OCCURRED DURING PATIENT USE, WHEN REMOVING THE SET FROM A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). 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 24059714 ↗
• MalfunctionJan 13, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MALE LUER ADAPTER OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE OFF. THIS OCCURRED DURING A HEPARIN INFUSION RUNNING THROUGH A PERIPHERAL IV (PIV) IN THE RIGHT FOREARM. THE INFUSION WAS PAUSED AND ATTEMPTED TO DISCONNECT THE HEPARIN LINE FROM THE PIV. WITH MINIMAL FORCE APPLIED TO TWIST THE COMPONENTS APART, THE ¿NECK¿ (MALE LUER ADAPTER) PORTION OF THE LINE BROKE OFF AND REMAINED INSIDE THE IV HUB. 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 24058304 ↗
• MalfunctionJan 7, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE CONNECTOR OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS STUCK AND UNABLE TO CONNECT TO THE CATHALON. THIS WAS OBSERVED 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 23990712 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM FAULTY UPPER OR LOWER PORTS/VALVES/CLAVES DURING DRUG PREPARATION OR ADMINISTRATION. 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 23989462 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD POSSIBLE PINHOLES RESULTING IN A LEAK. 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 23979426 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM AN UNSECURE CONNECTION TO AN EXTENSION SET. THIS WAS OBSERVED 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 23968908 ↗
• MalfunctionDec 31, 2025Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT THE PORT (MALE LUER CONNECTOR) OF AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS GOT STUCK AND THEREFORE, UNABLE TO CONNECT TO THE TO INTRAVENOUS (IV) SITE. THIS WAS OBSERVED DURING SET UP. 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 23938673 ↗
• MalfunctionDec 31, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT FOUR (4) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE DIFFICULT TO CONNECT TO THE PATIENT'S CATHETER. THIS OCCURRED DURING PATIENT INFUSION. 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 23936517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203609, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0193-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-0194-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
• Z-0794-2020 · Dec 12, 2019 · Open, Classified
  ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Pro
• Z-0475-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2920-2011 · Jul 21, 2011 · Terminated
  Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use
• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-1152-03 · Jul 16, 2003 · Terminated
  Interlink System Continu-Flo Solution Set with Microbore Tubing, 60 drops/mL, 128'', 3 injection sites, Male Luer Lock Adapter, catalog 2C6521; Baxter Healthcare Corporation, Deerf