CLEARLINK/CONTINU-FLO 2C8546Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00085412048987), received between Sep 24, 2019 and May 1, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

12 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A "8MMX3MM HOLE" WAS FOUND IN THE TUBING OF A CONTINU-FLO SOLUTION SET RESULTING IN A LEAK. THE LOCATION OF THE HOLE WAS BETWEEN THE SECOND AND THIRD LUER LOCKS (CLEARLINK) RESULTING IN A LEAK. THE ISSUE WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060534 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE LUER LOCK OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WAS HARD TO ATTACH TO THE CATHETER RESULTING IN A LEAK. THE LOCATION OF THE LEAK WAS DESCRIBED AS EITHER "FROM TOP OR THE BOTTOM OF THE LOCK". 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 23479376 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT THE BLUE "KEY" (SLIDE CLAMP) OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE HORIZONTALLY. THIS OCCURRED WHILE INSERTING THE SET INTO AN UNSPECIFIED INTRAVENOUS (IV) PUMP FOR 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 22529476 ↗
• MalfunctionJul 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD A PARTICULATE MATTER (PM) INSIDE THE TUBING. THE PM WAS CHARACTERIZED AS AN IRREGULAR DARK BROWN TO REDDISH PARTICLE MEASURING APPROXIMATELY 0.3MM IN LENGTH, WITH LIGHTER BROWN IN COLOR AT ONE END. IT SEEMED TO BE STUCK INSIDE THE TUBING BETWEEN THE MOST DISTAL AND MEDIAL PORT. ADDITIONALLY, THE PARTICLE APPEARED TO BE EMBEDDED; HOWEVER, IT WAS PROTRUDING INTO THE LUMEN OF THE LINE. THIS OCCURRED DURING PATIENT INFUSION WITH LACTATED RINGER'S SOLUTION (LRS). 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 22529374 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT THE BLUE SLIDE CLAMP OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET DISINTEGRATED IN THE SLIDE CLAMP SLOT OF A NOVUM IQ LARGE VOLUME PUMP. THIS OCCURRED DURING USE ON THE PEDIATRIC UNIT; HOWEVER, PATIENT INVOLVEMENT 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 22114835 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT BLUE CLAMP OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET DISINTEGRATED IN THE SLIDE CLAMP KEYHOLE OF A NOVUM IQ LARGE VOLUME PUMP. THE WAS OBSERVED DURING USE OF THE SET; HOWEVER, PATIENT INVOLVEMENT 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 22114773 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE OFF IN AN UNSPECIFIED LOCATION. THIS OCCURRED WHILE DISCONNECTING FROM THE PATIENT'S DIALYSIS CATHETER. 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 20351600 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET BROKE OFF WHILE DISCONNECTING FROM THE CATHETER. THIS 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 19716558 ↗
• MalfunctionJan 29, 2024Fluid/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 LEVOPHED DUE TO A SEPARATION BETWEEN THE INJECTION SITE (CLEARLINK COMPONENT) AND TUBING. THIS OCCURRED DURING THE SET UP, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602393 ↗
• MalfunctionDec 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD DARK PARTICULATE MATTER INSIDE THE TUBING; FURTHER DESCRIBED AS "SOMETHING IN THE LINE." THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409807 ↗
• MalfunctionJul 19, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET OCCLUDED WHILE ATTEMPTING TO RUN TOTAL PARENTERAL NUTRITION (TPN). 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 17350754 ↗
• MalfunctionMay 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS HAD A FOREIGN BODY STUCK AND IMMOBILE ON THE INSIDE OF THE TUBING WALL. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887455 ↗
• MalfunctionJun 7, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WOULD NOT FLOW. THE REPORTER STATED THAT THEY COULD NOT PUSH MEDICATION IN THE FIRST Y OF THE PROXIMAL TUBE WHICH CAUSES A CONSTANT STOP OF AN UNSPECIFIED PUMP. 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 14626832 ↗
• MalfunctionJun 7, 2022No Flow; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WOULD NOT FLOW. THE REPORTER STATED THAT THEY COULD NOT PUSH MEDICATION IN THE FIRST Y OF THE PROXIMAL TUBE WHICH CAUSES A CONSTANT STOP OF AN UNSPECIFIED PUMP. 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 14626770 ↗
• MalfunctionMay 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED. 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 14548257 ↗
• MalfunctionMay 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED. 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 14548253 ↗
• MalfunctionDec 10, 2019Device Contamination with Chemical or Other Material; Material Split, Cut or Torn; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET WAS INDENTED, AND HAD BROWN FOREIGN MATTER IN THE INDENTATION. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9445387 ↗
• MalfunctionNov 12, 2019Defective Device

  DEFECT NOTED ON IV TUBING SET. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9317602 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING FURTHER DESCRIBED AS ¿ON THE DISTAL END THAT YOU HOOK TO THE PATIENT, WHEN THE END IS SCREWED ONTO THE PATIENT, THE THREADS DO NO MATCH UP¿ CAUSING LEAKS. AS A RESULT, THE SET WOULD BE UNHOOKED AND RE-PRIMED. THIS WAS IDENTIFIED DURING PATIENT 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 9199438 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT TWO (2) OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING FURTHER DESCRIBED AS ¿ON THE DISTAL END THAT YOU HOOK TO THE PATIENT, WHEN THE END IS SCREWED ONTO THE PATIENT, THE THREADS DO NO MATCH UP¿ CAUSING LEAKS. AS A RESULT, THE SET WOULD BE UNHOOKED AND RE-PRIMED. THIS WAS IDENTIFIED DURING PATIENT 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 9194869 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE LEAKING FURTHER DESCRIBED AS ¿ON THE DISTAL END THAT YOU HOOK TO THE PATIENT, WHEN THE END IS SCREWED ONTO THE PATIENT, THE THREADS DO NO MATCH UP¿ CAUSING LEAKS. AS A RESULT, THE SET WOULD BE UNHOOKED AND RE-PRIMED. THIS WAS IDENTIFIED DURING PATIENT 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 9194843 ↗
• MalfunctionSep 24, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS DISCONNECTED FROM THE CONNECTOR RIGHT OUT OF THE PACKAGE. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9112484 ↗

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-0192-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
• 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-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-2594-2025 · Aug 8, 2025 · Open, Classified
  Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration s
• Z-1011-2025 · Dec 20, 2024 · Open, Classified
  Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
• Z-0793-2020 · Dec 12, 2019 · Open, Classified
  Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vas
• 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