CLEARLINK/CONTINU-FLO/DUO-VENT UC8519Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00085412486512), received between Feb 4, 2019 and May 7, 2026 — classified as 66 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (49 reports).

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

11 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 18, 2026.

Recalls naming this device

1. Dec 20, 2024Class IIOpen, Classified

   Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

   Z-1011-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED FROM THE TOP OF THE DRIP CHAMBER. THIS WAS OBSERVED AFTER SPIKING A BAG OF NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113210 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM THE VENT CAP CONNECTION PIECE. THIS WAS OBSERVED DURING COMPOUNDING PRIOR TO PATIENT USE. THE TUBINGS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472377 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM THE BLUE VENT PORT. AFTER SPIKING A BAG OF SALINE BEFORE PRIMING, IT WAS OBSERVED THAT THE SET BEGAN TO LEAK OUT FROM THE SIDE OF THE BLUE VENT PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470997 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE VENT CAP CONNECTION PIECE. THIS WAS OBSERVED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470403 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE LEAKED AT THE BLUE VENT PORT ABOVE THE FILL CHAMBER. THIS OCCURRED DURING PATIENT INFUSION WITH TOTAL PARENTERAL NUTRITION IN THE NEONATAL INTENSIVE CARE UNIT. THE TUBING WAS 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 24366126 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE LEAKED AT THE VENT CAP (BLUE PORT) BELOW THE INSERT SPIKE. THIS OCCURRED DURING PATIENT INFUSION IN THE NEONATAL INTENSIVE CARE UNIT. THE TUBING WAS 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 24365799 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED WHILE SPIKING D10(10% DEXTROSE IN WATER) WITH SODIUM CHLORIDE (NACL). IT WAS FURTHER REPORTED THAT "WE BELIEVE THE LEAK OCCURRED AT THE BLUE VENT AREA OF THE TUBING". A NEW DEVICE WAS PRIMED SUCCESSFULLY 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 24365556 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING AT THE BLUE FILTER BETWEEN THE CHAMBER AND SPIKE. THIS ISSUE WAS DESCRIBED AS, ¿TUBING START LEAKING AT THE BLUE FILTER BETWEEN THE CHAMBER AND THE SPIKE AFTER CONNECTING THE STERILE LINE¿. TO RESOLVE THIS ISSUE, AND NEW SET WAS USED. 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 24365084 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED AT ONE OF THE SEAMS. THIS OCCURRED DURING PRIMING WITH SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327628 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE DRIP CHAMBER 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 24326657 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED NORMAL SALINE FROM THE BLUE VENT UPON SPIKING A BAG. 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 24316947 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE DRIP CHAMBER. THE DEVICE CONTAINED AN UNSPECIFIED MEDICATION. THIS OCCURRED 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 24313898 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED AT THE TOP WHERE THE AIR VENT WAS LOCATED. THE ISSUE OCCURRED DURING SPIKING OF NORMAL SALINE TO PRIME BAG. 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 24308629 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE AIR VENT OF A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING. THE LEAK WAS OBSERVED WHEN NORMAL SALINE WAS SPIKED TO PRIME BAG. 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 24307574 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING WHILE SPIKING. A PATIENT WAS CONNECTED 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 24304474 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED AN UNKNOWN QUANTITY OF CONTINU-FLO SOLUTION SETS LEAKED. THE EVENTS OCCUR WHEN THE NURSE SPIKES A SOLUTION BAG (SALINE BAG FOR EXAMPLE) TO PRIME THE TUBING AND ONCE INVERTED THE SALINE LEAKS FROM THE VENT ABOVE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205629 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED AN UNKNOWN QUANTITY OF CONTINU-FLO SOLUTION SETS LEAKED. THE EVENTS OCCUR WHEN THE NURSE SPIKES A SOLUTION BAG (SALINE BAG FOR EXAMPLE) TO PRIME THE TUBING AND ONCE INVERTED THE SALINE LEAKS FROM THE VENT ABOVE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205622 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM THE CONNECTION THE TOTAL PARENTERAL NUTRITION (TPN) FILTER TUBING AND THE TRIPLE PORT. 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 24171206 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WERE LEAKING. ONE SET WAS LEAKING FROM THE TUBING, AND THE OTHER SET WAS LEAKING FROM THE SITE WHERE THE LINE MERGED. 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 24171066 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING OUT OF THE BLUE PIECE ON THE FILTER JUST BELOW THE SPIKE AFTER BAG WAS SPIKED. 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 24169913 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED FROM AN UNSPECIFIED LOCATION. 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 24081142 ↗
• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE WAS LEAKING FROM THE SITE AROUND THE VENT CAP AT THE TOP OF THE SET. THE PATIENT¿S PICC LINE WAS HUNG AFTER ATTACHING THE CLEARLINK SYSTEM TO A TPN (TOTAL PARENTERAL NUTRITION) BAG AND IT WAS NOTED THAT THE SITE AROUND THE VENT CAP AT THE TOP OF THE SET WAS LEAKING TPN. THE DEFECTIVE SET WAS REMOVED, AND A NEW SET WAS REPLACED AND USED WITH NO FURTHER ISSUE. THIS ISSUE WAS IDENTIFIED DURING PREPARATION AT NICU (NEONATAL INTENSIVE CARE UNIT). 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 FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944804 ↗
• MalfunctionJan 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE SPIKING A BAG OF DEXTROSE WITH A CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE, FLUID BEGAN TO LEAK AROUND THE CLEARLINK. THE DEFECTIVE SET WAS REMOVED, AND A NEW SET WAS REPLACED AND USED WITH NO FURTHER ISSUE. THIS ISSUE WAS IDENTIFIED DURING PREPARATION AT NICU (NEONATAL INTENSIVE CARE UNIT). 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 FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943817 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS WERE SPIKED INTO UNSPECIFIED TOTAL PARENTERAL NUTRITION (TPN) BAGS, RESULTING IN A LEAKAGE. THE ISSUE WAS FURTHER DESCRIBED AS, WHEN SPIKING THE TPN BAG WITH THE TUBING, THEY NOTICED THE BAG WAS BEGINNING TO LEAK. THE BLUE PORT AT THE TOP OF THE BAG BEGAN TO LEAK TPN. THIS OCCURRED DURING PATIENT INFUSION. THE TUBING 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 23743376 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM EXTENSION SET LEAKED FROM "THE BLUE PORT IN THE SPIKE" OF THE TUBING. THE ISSUE WAS NOTICED WHEN HANGING THE LINE AFTER SPIKING THE TOTAL PARENTERAL NUTRITION (TPN) BAG. THE BAG WAS TURNED UPSIDE DOWN AND A NEW DEVICE WAS USED 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 23480490 ↗

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-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-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-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-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-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