NA 1C8160Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412020594), received between Sep 19, 2022 and Jun 11, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET SPIKE BROKE OFF AT THE END OF THE INFUSION BAG ATTACHED TO THE PHASEAL, RESULTING IN CHEMOTHERAPY SOLUTION LEAKAGE. THE EVENT WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470657 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A MALE LUER LOCK ADAPTER SOLUTION SET HAD A PINHOLE LEAK IN THE TUBING. THIS WAS NOTICED WHEN PRIMING THE SET FOR ADMINISTRATION OF METHYLPREDNISOLONE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552071 ↗
• MalfunctionNov 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT EIGHT (8) SOLUTION SETS WERE LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAKS WERE 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 18210337 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SOLUTION SET LEAKED ABOVE THE BLUE CLAMP. THIS WAS IDENTIFIED DURING PATIENT INFUSION WITH CARBO. 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 18135895 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A SOLUTION SET WAS FOUND LEAKING UNDER THE ROLLER CLAMP. THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17540806 ↗
• MalfunctionMar 17, 2023Break; Disconnection; Fluid/Blood Leak; Break; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INSERT SPIKE OF A SOLUTION SET BROKE OFF INTO THE SOLUTION CONTAINER WHICH RESULTED IN A FLUID LEAK. THIS ISSUE OCCURRED AFTER SPIKING THE SOLUTION BAG DURING SETUP/PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567190 ↗
• MalfunctionSep 19, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TWO (2) CASES OF SOLUTION SETS WERE INCORRECTLY LABELED. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447878 ↗

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