Skip to content

CLEARLINK/CONTINU-FLO 1C8722Recalls & reported problems

Baxter International Inc. · CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter, Extension Set, 2 Luer Activated Valves, Male Luer Lock Adapter, Extension Set, Male Luer Lock Adapter with Retractable Collar · Class 2

All models of CLEARLINK/CONTINU-FLO (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412074429), received between May 18, 2018 and May 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (1 report).

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 18, 2026.

Most reported problems

Device problems

  • Hole In Material1
  • No Flow1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2018Hole In Material; Hole In Material

    IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD A HOLE IN AN UNSPECIFIED LOCATION ON THE DEVICE. THIS EVENT WAS DISCOVERED DURING PATIENT INFUSION. 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 7525599 ↗
  • MalfunctionMay 18, 2018No Flow; No Flow

    IT WAS REPORTED THAT A THERE WAS NO FLOW THROUGH A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THIS EVENT WAS DISCOVERED DURING PATIENT INFUSION. 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 7525594 ↗

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-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-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-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

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page