CLEARLINK/CONTINU-FLO 2R8537Recalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00085412565743), received between Jul 27, 2020 and Sep 24, 2026 — classified as 1 injury, 135 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (85 reports).

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

12 other recalls cover devices cleared under the same FDA submission (K180739, 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. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0202-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889044 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757167 ↗
• MalfunctionJul 8, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP CONTINU-FLO SOLUTION SET SEPARATED AT THE MID Y-JUNCTION (CLEARLINK). THIS WAS OBSERVED DURING PRIMING WITH NEUTRAL SOLUTION IN PREPARATION FOR CHEMOTHERAPY INFUSION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753282 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE LOWEST Y-SITE (CLEARLINK). THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402847 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS "EJECTING SALINE FROM Y SITE BELOW PUMP". 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 25402624 ↗
• MalfunctionJun 4, 2026Backflow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET BACKED UP CHEMOTHERAPY DRUG PAST THE BACKFLOW VALVE UP INTO THE DRIP CHAMBER. THE ISSUE WAS NOTICED DURING METHOTREXATE INFUSION AT 23 CC/HR, ABOUT 3 HOURS AFTER THE CHEMOTHERAPY STARTED. THE CHEMOTHERAPY WAS HUNG AS A SECONDARY LINE, AND THE NORMAL SALINE (NS) BAG WAS HUNG LOWER USING BLUE DROP HANGERS. 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 25402274 ↗
• MalfunctionMay 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET HAD A CUT/CRACK IN THE TUBING; THE TUBING WAS IN TWO PIECES. THIS WAS OBSERVED UPON OPENING THE PRIMARY TUBING PACKAGING, PRIOR TO UNRAVELING THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311612 ↗
• MalfunctionMay 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET LEAKED AT THE Y-SITE ABOVE THE INFUSION PUMP. THE EVENT OCCURRED DURING INFUSION OF NORMAL SALINE. 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 25260791 ↗
• MalfunctionMay 7, 2026Unintended Movement; Air/Gas in Device

  IT WAS REPORTED THAT AN AIR IN LINE ALARM WAS TRIGGERED ONCE A PRIMARY INFUSION RESUMED. THIS WAS OBSERVED DURING USE OF AN UNSPECIFIED QUANTITY OF NON-DEHP CONTINU-FLO SOLUTION SETS, AFTER A SECONDARY INFUSION COMPLETED USING NON-BAXTER SECONDARY SETS. WITH DIFFERENT SIZE INTRAVENOUS (IV) BAGS AND SET UP VARIATIONS, IT WAS OBSERVED THAT THE DRIP CHAMBER ON THE PRIMARY BAG COULD TIP AND AIR DRAWN INTO THE IV TUBING. 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 25113542 ↗
• MalfunctionMay 7, 2026Backflow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON DEHP CONTINU FLO SOLUTION SET HAD BACK FLOW DURING PATIENT INFUSION. THE ISSUE WAS DESCRIBED AS FLUID SIPHONING FROM THE PRIMARY IV BAG WHILE THE SECONDARY INFUSION WAS RUNNING AT 272 ML/HR. THE PRIMARY BAG WAS LOWERED ON AN ADDITIONAL BLUE HANGER; HOWEVER, THE SIPHONING CONTINUED. THE NURSE THEN CLAMPED THE PRIMARY LINE, AND THE SPECTRUM IQ PUMP ALARMED FOR AN UPSTREAM OCCLUSION. THE CLAMP WAS REMOVED, AND THE INFUSION WAS CONTINUED. EACH TIME THE NURSE ATTEMPTED TO CLAMP THE LINE, THE TUBING DISTAL TO THE CLAMP COLLAPSED. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE NON BAXTER CLOSED SYSTEM TRANSFER DEVICE (CSTD) CONNECTIONS WERE NOT FULLY ENGAGED. THE CONNECTIONS WERE PROPERLY RECONNECTED AND THE SIPHONING STOPPED. 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 25109423 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED MEDICATION THROUGH A PUNCTURE FROM THE JUNCTION BELOW THE Y-SITE (CLEARLINK). AT THE TIME OF THE EVENT, THE PRIMARY IV TUBING (SOLUTION SET) WAS CONNECTED TO THE PATIENT INFUSING 0.9% NORMAL SALINE, WITH A SECONDARY SET DELIVERING ANTIBIOTICS. SHORTLY AFTER INITIATION OF THE SECONDARY INFUSION, THE BEDSIDE NURSE OBSERVED LEAKING FROM THE PUNCTURE, WITH A "LARGE PUDDLE ON FLOOR" AND MEDICATION NOTED ON THE PATIENT¿S BED. THE LINE WAS DISCONNECTED AND A NEW LINE WAS PRIMED. 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 24957162 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP CONTINU-FLO SOLUTION SET SEPARATED FROM THE Y-SITE, RESULTING IN LEAKAGE. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912267 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED AT THE Y-SITE. THE PRIMARY NURSE WAS PRIMING THE IV SET WITH NORMAL SALINE AND NOTICED THERE WAS LEAKING AROUND ONE OF THE LUER LOCK HUBS. AS THE NURSE WAS TAKING THE TUBING OFF THE POLE, THE TUBING BENEATH THE LUER LOCK DISCONNECTED. 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 24867050 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET HAD A HOLE IN THE IV TUBING BELOW THE MIDDLE PORT, RESULTING IN LEAKAGE. THE SET HAD BEEN PRIMED WITH NORMAL SALINE WITH NO ISSUES NOTED. THE EVENT OCCURRED WITHIN 10 MINUTES OF INITIATING AN IRON SUCROSE 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 24866728 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS STATED THAT THE TUBING OF A NON DEHP CONTINU FLO SOLUTION SET SEPARATED FROM THE Y-SITE CLEARLINK LUER DURING A CISPLATIN INFUSION. APPROXIMATELY 100ML OF SOLUTION, FROM A TOTAL VOLUME OF 500 ML, WAS FOUND ON THE FLOOR. 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 24778123 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED DURING NORMAL SALINE PRIMING. UPON INSPECTION OF THE IV TUBING, HEALTHCARE PROFESSIONAL NOTICED A HOLE IN THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746237 ↗
• MalfunctionMar 25, 2026Filling Problem

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS BEING USED DURING AN UNDERINFUSION OF FLAGYL. THIS OCCURRED DURING USE WITH A BAXTER INFUSION PUMP. THE UNDERINFUSION WAS NOTED TO BE GREATER THAN 10%. CLINICIANS RETURNED TO THE BEDSIDE AT THE INFUSION COMPLETE SCREEN/ALARM AND FOUND THAT THE MEDICATION HAD NOT INFUSED, DESPITE THE PUMP HAVING TRANSMITTED INTAKE VOLUME DATA CONSISTENT WITH A COMPLETED 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 24690328 ↗
• MalfunctionMar 25, 2026Filling Problem

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WAS BEING USED DURING AN UNDERINFUSION OF VANCOMYCIN. THIS OCCURRED DURING USE WITH A BAXTER INFUSION PUMP. THE UNDERINFUSION WAS NOTED TO BE GREATER THAN 10%. CLINICIANS RETURNED TO THE BEDSIDE AT THE INFUSION COMPLETE SCREEN/ALARM AND FOUND THAT THE MEDICATION HAD NOT INFUSED, DESPITE THE PUMP HAVING TRANSMITTED INTAKE VOLUME DATA CONSISTENT WITH A COMPLETED 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 24689949 ↗
• MalfunctionMar 18, 2026Backflow

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON DEHP CONTINU FLO SOLUTION SET HAD A BACKFLOW. THE ISSUE WAS DESCRIBED AS FOLLOWS: THE SECONDARY IV BAG WAS POSITIONED LOWER THAN THE PRIMARY 1000 ML BAG. THE UNSPECIFIED SECONDARY SET, CONNECTED TO THE UPPER Y SITE OF THE PRIMARY SET, WAS ATTACHED TO AN EMPTY SECONDARY BAG OF UNKNOWN VOLUME THAT HAD PREVIOUSLY CONTAINED FLUIDS AND CHEMOTHERAPY. DURING THE FLUSHING PROCESS, THE LINE VISIBLY CLEARED OF CHEMOTHERAPY; HOWEVER, CHEMOTHERAPY BACKFLOWED INTO THE DRIP CHAMBER OF THE PRIMARY FLUID 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 24626283 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET LEAKED 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 24610070 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THREE (3) CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SETS SEPARATED AT THE LOWEST Y-SITE (CLEARLINK) RESULTING IN LEAKS. THE ISSUE OCCURRED WHILE PRIMING NORMAL SALINE DURING ROUTINE COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436963 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET LEAKED THROUGH THE LUER LOCK CONNECTOR CLOSEST TO THE PATIENT. THIS OCCURRED DURING IRON 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 24324902 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM; NON-DEHP CONTINU-FLO SOLUTION SET LEAKED FROM THE BONDED JOINT BETWEEN THE INJECTION SITE (CLEARLINK) AND THE TUBING. THE ISSUE 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 24324275 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK NON-DEHP CONTINU-FLO SOLUTION SET WAS DAMAGED WHICH RESULTED IN A FLUID LEAK. THE LEAK OCCURRED DUE TO VISIBLE IRREGULARITIES ON THE TUBING. THE SET WAS LEAKING NORMAL SALINE WHILE PRIMING THE SET PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308999 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED LOCATION. 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 24205501 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180739, K961225. One submission often covers many models, so check the product and lot details in each record.

• Z-0201-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
• Z-0203-2026 · Aug 29, 2025 · Open, Classified
  CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-i
• Z-1009-2025 · Dec 20, 2024 · Open, Classified
  Baxter Solution Set with Duo-Vent Spike, REF 2R8404
• Z-1010-2025 · Dec 20, 2024 · Open, Classified
  Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
• Z-1291-2024 · Feb 8, 2024 · Open, Classified
  CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
• 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