INTERLINK 2C6425Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412002149), received between Apr 30, 2018 and Oct 1, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM SOLUTION SETS WERE FORMING CUTS, AND THE CLIPS WERE REDUCING FLUID FLOW. THIS ISSUE WAS DESCRIBED AS, ¿TUBES ARE FORMING CUTS ON THEIR OWN AND THE CLIPS ARE REDUCING FLUID TO PASS¿. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348918 ↗
• MalfunctionApr 12, 2022Backflow; Complete Blockage; Device Dislodged or Dislocated; Backflow; Complete Blockage; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE GUMMY STOPPER (INJECTION PORT) OF AN INTERLINK SYSTEM SOLUTION SET BECAME DISLODGED AND WENT INTO THE TUBING CLOGGING IT. WHEN THIS OCCURRED, THE MEDICATION BACKED UP INTO THE IV (INTRAVENOUS) BAG AND FLUIDS WOULD NOT RUN. THE ISSUE WAS IDENTIFIED WHILE THE NURSE WAS INJECTING MEDICATION INTO THE Y-PORT. 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 14090803 ↗
• InjuryMar 21, 2022Device Dislodged or Dislocated

  PRODUCT 2C6425 BAXTER: I V TUBING, AT THE Y PORT SITE, THE RUBBER PART THAT THE NEEDLE INJECTS INTO WILL SOMETIMES DISLODGE, WHICH IN TURN WILL CLOG THE ENTIRE IV LINE. IN THIS CASE A PT WAS BEING PUT TO SLEEP FOR ANESTHESIA AND IV ACCESS WAS COMPROMISED BECAUSE OF THIS ISSUE, NO DRUGS OR FLUIDS COULD GET TO PT UNTIL THE LINE WAS COMPLETELY CHANGED FOR NEW TUBING. ALSO, THE SAME TUBING BRAND (NOT SURE OF LOT NUMBER) HAS CAUSED THIS SAME PROBLEM ABOUT 3 OR 4 OTHER TIMES. ANOTHER ISSUE WITH THE SAME TUBING BRAND IS THAT IT IS NOTICED THAT WHEN TRYING TO GIVE MEDICATIONS THRU THE Y PORT, THE MEDICATIONS WILL ACTUALLY BACK UP INTO THE BAG, AND NOT GOING DOWN TO THE PATIENT. IT WAS NOT NOTED AT THE TIME THAT THE YPORT RUBBER PART HAD DISLODGED IN THESE CASES. LOT NUMBER OF TUBING IN TODAY'S EVENT IS (10)R21F24069. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13847930 ↗
• MalfunctionDec 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET WAS LEAKING FROM THE 'ANGIO' CAP AND THE END OF THE TUBING. IT WAS FURTHER REPORTED THAT THERE WAS NO PHYSICAL DAMAGE TO THE SET OR THREADING AND THAT THE TUBING WAS PROPERLY TIGHTENED. THE ISSUE WAS IDENTIFIED DURING 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 12969739 ↗
• MalfunctionFeb 10, 2021Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT AN INTERLINK SOLUTION SET WAS LEAKING FROM THE TUBING NEAR THE ROLLER CLAMP. THE LEAK WAS OBSERVED DURING PRIMING WHEN THE CLAMP WAS OPENED, AND DROPLETS BEGAN TO LEAK FROM THE TUBING. IT WAS FURTHER REPORTED THAT CLEAR KINK MARK WAS FOUND ON THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11307203 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF AT LEAST FOUR (4) INTERLINK SOLUTION SETS WERE LEAKING FROM THE PROXIMAL PORT CLOSEST TO THE PATIENT FOLLOWING MEDICATION DELIVERY THROUGH THE PORT. THIS ISSUE WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10612266 ↗
• MalfunctionSep 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN EIGHT (8) SOLUTION SETS; FURTHER DESCRIBED AS "BROWN AND NASTY INSIDE". THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10516412 ↗
• MalfunctionAug 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN 10 SOLUTION SETS. THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10382251 ↗
• MalfunctionAug 6, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERLINK SOLUTION SET LEAKED. IT WAS FURTHER REPORTED THAT THE SET WAS BROKEN AFTER CONNECTING TO THE PATIENT'S ANGIOCATHETER; INTRAVENOUS (IV) FLUID DRIPPED ON THE HANDS. IT WAS NOTED THAT THE MALE LUER CONNECTOR SEPARATED FROM THE TUBING. 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 8866804 ↗
• MalfunctionApr 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN INTERLINK SOLUTION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED BEFORE PRODUCT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8536821 ↗
• MalfunctionApr 30, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE MALE LUER DETACHED FROM THE TUBING OF A SOLUTION SET RESULTING IN A LEAK. THIS OCCURRED WHEN THE NURSE WAS ATTEMPTING TO ATTACH THE SET TO AN UNSPECIFIED DEVICE. 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 7472663 ↗

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-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-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