CLEARLINK 2N8374Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412048901), received between Jan 24, 2019 and Nov 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K112893); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE LUER LOCK (CLEARLINK) OF AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM CATH. EXT. SETS WAS HARD TO DISCONNECT TO ATTACH A NON-BAXTER BLOOD COLLECTION SET. THIS WAS OBSERVED DURING BLOOD COLLECTION FROM PATIENTS. TO RESOLVE THE EVENT, THE NURSES WOULD GET A NEW EXTENSION SET THAT COULD BE DISCONNECTED TO COMPLETE THE BLOOD COLLECTION PROCEDURE. 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 18188193 ↗
• MalfunctionJun 14, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A BOX OF CLEARLINK SYSTEM CATH. EXT. SET HAD WATER DAMAGE ON ARRIVAL. THE STERILE PACKAGING WAS WET AND OPENED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127624 ↗
• MalfunctionApr 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CATHETER EXTENSION SET WAS LEAKING FROM AROUND WHERE THE SET SCREWS INTO THE TUBING. THE LEAK WAS DISCOVERED WHILE ADMINISTERING CONTRAST TO THE PATIENT. 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 11665524 ↗
• MalfunctionJan 24, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LUER LOCK TIP OF A CLEARLINK LUER ACTIVATED VALVE CAME "UNDONE". IT WAS FURTHER DESCRIBED BY THE CUSTOMER AS "WHEN SCREWING THE EXTENSION SET TO THE IV (INTRAVENOUS) CATHETER, IT WAS NOTED TO FALL OUT AND NOT SECURE OR SCREW ON CORRECTLY". THIS WAS IDENTIFIED AT AN UNSPECIFIED PROCESS STEP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8275786 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112893. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
• Z-0197-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
• Z-0190-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
• Z-0198-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
• Z-0199-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
• Z-1653-2022 · Aug 9, 2022 · Terminated
  Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
• Z-0099-2014 · Sep 4, 2013 · Terminated
  Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
• Z-1271-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte