CLEARLINK/CONTINU-FLO 2C8537Recalls & reported problems

Summary

The FDA's MAUDE database contains 490 adverse event reports that list this exact device (DI 00085412048970), received between Dec 28, 2017 and Sep 30, 2026 — classified as 10 injuries, 480 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (278 reports).

2 FDA recall records name this device's identifier, 2 still open.

10 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.

Recalls naming this device

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0193-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Dec 12, 2019Class IIOpen, Classified

   Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

   Z-0793-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 490 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953904 ↗
• MalfunctionSep 26, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50906579 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875508 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695520 ↗
• MalfunctionAug 4, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132159 ↗
• MalfunctionJul 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS GENERATED "AIR IN LINE" ALARMS ON IV PUMPS. THE EVENTS REPORTEDLY OCCURRED WHEN CLINICIANS "HANG A BAG OF FLUID OR ANTIBIOTICS" FOR INFUSION. THE REPORTER WAS UNSURE IF "THE TUBING HAS SOME KIND OF GAS IN IT WHICH MIGHT BE CAUSING THE AIR IN THE LINE." AS A RESULT, NURSES REPORTEDLY EITHER REMAINED WITH THE PUMP FOR AN ADDITIONAL FIVE MINUTES AWAITING ALARM ACTIVATION OR REMOVED AND REPLACED THE TUBING TO RESTART THE INFUSION SETUP. 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 25704600 ↗
• MalfunctionJun 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS OBSERVED ENTERING A CONTINU-FLO SOLUTION SET. THE EVENT OCCURRED AFTER PRIMING AN IV EMEND INFUSION. THE TUBING WAS CLAMPED, LOADED INTO THE INFUSION PUMP, AND HUNG ON AN IV POLE; SUBSEQUENTLY, THE NURSE NOTED THAT FLUID CONTINUED TO DRIP FROM THE END OF THE TUBING, AND AIR WAS OBSERVED REENTERING THE TUBING. THE NURSE THEN CLAMPED THE END OF THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408789 ↗
• MalfunctionMay 28, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET DISCONNECTED FROM ¿THE MIDDLE LUER-ACTIVATED SURFACE PORT¿ (CLEARLINK). THE EVENT OCCURRED AFTER THE ROUTINE PRIMING OF AN IV SOLUTION WITH NORMAL SALINE WHILE ATTEMPTING TO CLOSE THE REGULATING CLAMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320165 ↗
• MalfunctionMay 19, 2026Fitting Problem

  IT WAS REPORTED THAT THE LUER LOCK OF AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS DID NOT CONNECT TO A CATHETER. THE REPORTER STATED THAT THE "LUER LOCK THAT CONNECTS THE IV TUBING TO THE CATHETER GETS LOCKED IN PLACE. THE BLUE CAP SHOULD COME OFF AND THEN THE LUER LOCK GETS PULLED FORWARD TO CONNECT TO THE CATHETER. [THEY] HAVE HAD MULTIPLE OCCURRENCES OF THIS NOT HAPPENING". AS A RESULT, NURSES WERE REQUIRED TO HOLD PRESSURE ON THE CATHETER WHILE ANOTHER NURSE PRIMED A REPLACEMENT SET. 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 25221242 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED OUT OF ONE OF THE VALVES. THE ISSUE WAS NOTICED WHEN AN ANTIBIOTIC WAS HUNG WITH THE PRIMARY TUBING 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 25219314 ↗
• MalfunctionMay 14, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS HAD BUBBLES IN THE LINE. THIS WAS OBSERVED WHEN THE NURSE WENT TO USE THE DEVICES. THE NURSES HAD PRIMED THE SETS AND GOTTEN ALL THE BUBBLES OUT IN PREPARATION FOR THE PATIENT, PRIOR TO 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 25174795 ↗
• MalfunctionMay 14, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS HAD BUBBLES IN THE LINE. THIS WAS OBSERVED WHEN THE NURSE WENT TO USE THE DEVICES. THE NURSES WOULD PRIME THE SETS AND GET ALL THE BUBBLES OUT IN PREPARATION FOR THE PATIENT, PRIOR TO 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 25174711 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED FROM A LUER CONNECTOR. THIS WAS OBSERVED DURING A RAPID INFUSION OF OCREVUS. 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 25130621 ↗
• InjuryMay 7, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CLEARLINK CONTINU FLO SOLUTION SET LEAKED BLOOD FROM A "PINPOINT HOLE IN TUBING". THE EVENT OCCURRED AFTER THE PATIENT RETURNED FROM AN MRI/CT PROCEDURE AND WAS RECONNECTED TO MONITORING IN THE CVICU. WHILE THE INFUSION PUMP WAS RUNNING LEVOPHED, THE REGISTERED NURSE (RN) OBSERVED BLOOD BACKING UP INTO THE IV TUBING, FOLLOWED BY A DROP IN THE PATIENT¿S BLOOD PRESSURE. THE RN IMMEDIATELY BEGAN SETTING UP A NEW PUMP AND CALLED FOR ASSISTANCE. AT THAT TIME, BLOOD WAS OBSERVED DRIPPING ONTO THE FLOOR FROM A PINPOINT HOLE IN THE TUBING. THE RN STOPPED THE INFUSION, DISCONNECTED THE TUBING, AND OBTAINED EMERGENCY LEVOPHED AND NEW TUBING TO REPRIME THE IV LINE. DURING THIS TIME, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE REPORTEDLY DECREASED TO THE 50 TO 60 MMHG RANGE. A MEDICAL DOCTOR WAS PRESENT AT THE BEDSIDE, AND A NEOSYNEPHRINE PUSH DOSE WAS ADMINISTERED WITH MINIMAL IMPROVEMENT. A NEW PUMP, TUBING, AND LEVOPHED INFUSION WERE INITIATED, AFTER WHICH THE PATIENT¿S BLOOD PRESSURE RETURNED TO BASELINE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 25111504 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED AT THE MIDDLE Y-PORT. THE LEAK OCCURRED AT THE CONNECTION OF AN UNSPECIFIED SET TO THE Y-PORT. THE EVENT OCCURRED DURING SACITUZUMAB 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 25050258 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD "BROKEN AT THE POINT OF CONNECTION WITH THE Y-PORT. REMAINDER OF TUBING WAS ATTACHED TO PATIENT'S PICC LINE, OPEN TO AIR. NO APPARENT INFUSION OF AIR AS IT WAS NOTED THAT THERE WAS FLUID IN THE TUBING UP TO THE POINT OF DISCONNECTION.¿ THIS OCCURRED DURING USE IN THE INTENSIVE CARE UNIT (ICU). NO ISSUES WERE NOTED WITH THE PICC LINE. NO MEDICATION WAS ACTIVELY INFUSING THROUGH THE TUBING AT TIME ISSUE WAS NOTED. 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 25021866 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET BROKE AT THE TERMINAL END INTO PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DURING VANCOMYCIN THERAPY. A DISTAL PIECE OF THE IV TUBING SEPARATED AND BECAME LODGED INSIDE THE PICC LINE. THE PICC LINE WAS SUBSEQUENTLY REMOVED AT COMPLETION OF ANTIBIOTIC THERAPY, WITH THE BROKEN TUBING SEGMENT REMAINING INSIDE THE CATHETER AT THE TIME OF REMOVAL. 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 24966771 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED BETWEEN THE TUBING AND THE DRIP CHAMBER. THE EVENT OCCURRED DURING PRIMING. THE TUBING APPEARED TO BE TWISTED IN THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901807 ↗
• MalfunctionApr 2, 2026Mechanical Jam; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET COULD NOT BE CONNECTED TO A MICRON FILTER BY THE MALE LUER ADAPTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772608 ↗
• InjuryApr 1, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED DURING AN INFUSION OF NOREPINEPHRINE. THE THREADED LUER LOCK ADAPTER ON THE IV SET BROKE, CAUSING THE TUBING TO DISCONNECT FROM THE ONELINK AND RESULTING IN LEAKAGE OF MEDICATION INTO THE PATIENT¿S BED. THE REGISTERED NURSE TITRATED THE MEDICATION WITHOUT OBSERVING AN EXPECTED INCREASE IN BLOOD PRESSURE SUBSEQUENTLY IDENTIFIED THE TUBING FAILURE DURING ASSESSMENT. THE IV SET WAS REMOVED AND REPLACED. ICU LEADERSHIP CONFIRMED THAT THE PATIENT EXPERIENCED TEMPORARY HYPOTENSION, WHICH RESOLVED AFTER THE TUBING ISSUE WAS IDENTIFIED AND CORRECTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24757680 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED. DURING AN INFUSION OF UNSPECIFIED IV FLUIDS VIA AN UNKNOWN PUMP, THE CONTINU-FLO SOLUTION SET WAS OBSERVED ¿DISCONNECTED AT Y-SITE ABOUT MID TUBING.¿ THE DISCONNECTION RESULTED IN A ¿SMALL AMOUNT OF BLOOD PUDDLE¿ (VOLUME OF BLOOD LOSS NOT REPORTED) IN THE BED AND ON THE FLOOR ALONG WITH THE IV SOLUTION ON THE FLOOR. THE PATIENT WAS ASLEEP AT THE TIME AND COULD NOT RECALL WHETHER THE TUBING HAD BEEN PULLED OR FELT TIGHT. THE EVENT OCCURRED IN THE EMERGENCY DEPARTMENT. 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 24744866 ↗
• MalfunctionMar 31, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET "HAD A BROKEN LINE" AT FIRST HUB AFTER THE ROLLER CLAMP. THE ¿LINE BROKE/DISCONNECTED AT FIRST HUB AFTER THE ROLLER CLAMP¿ AFTER THE CLINICIAN ¿SPIKED A NEW BAG OF MILRINONE¿ IN THE PEDIATRIC MEDICAL SURGICAL UNIT. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. 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 24742892 ↗
• MalfunctionMar 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A "FOREIGN OBJECT" WAS OBSERVED IN A CONTINU-FLO SOLUTION SET. THIS OCCURRED DURING INFUSION. THE PARTICULATE MATTER WAS DESCRIBED AS A "BLACK "KNOTTED" SUTURE LOOKING MATERIAL"; THE NURSE WAS ABLE TO REMOVE IT FROM THE TUBING. NEXT DAY MORE BLACK SUBSTANCE WAS SEEN IN TUBING; TUBING WAS NOT REMOVED AFTER THE FIRST OCCURRENCE, SO THE SECOND OCCURRENCE WAS WITH THE SAME 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 24719585 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CONTINU-FLO SOLUTION SETS WERE LEAKING FROM AN UNSPECIFIED LOCATION WHILE INFUSING TPN (TOTAL PARENTERAL NUTRITION). 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 24694044 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET LEAKED DURING AN UNSPECIFIED PROCESS STEP. THE LINE HAD BEEN PRIMED WITH 5% DEXTROSE IN WATER PRIOR TO CONNECTION WITH THE PATIENT. THE NURSE NOTICED THAT THE TUBE WAS LEAKING FROM A SLICE OR HOLE NEAR DISTAL END OF THE SET. 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 24670563 ↗

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-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-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