CLEARLINK/CONTINU-FLORecalls & reported problems across all models

We found 12 models of CLEARLINK/CONTINU-FLO by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 824 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2017 and Sep 30, 2026 — classified as 11 injuries, 813 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (494 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CLEARLINK/CONTINU-FLO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

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

2. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0201-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0196-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

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

5. Aug 29, 2025Class IIOpen, Classified

   IV sets may leak.

   Z-0189-2026 · Root cause: Process control · Recall details · FDA record ↗

6. 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 CLEARLINK/CONTINU-FLO problems

CLEARLINK/CONTINU-FLO models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CLEARLINK/CONTINU-FLO 2C8537

  Set, administration, intravascular
  2 recalls490 reports
• CLEARLINK/CONTINU-FLO 2R8537

  Set, administration, intravascular
  1 recall136 reports
• CLEARLINK/CONTINU-FLO 2R8519

  Set, administration, intravascular
  1 recall37 reports
• CLEARLINK/CONTINU-FLO 2C6255

  Set, administration, intravascular
  1 recall30 reports
• CLEARLINK/CONTINU-FLO 2R8546

  Set, administration, intravascular
  59 reports
• CLEARLINK/CONTINU-FLO 2C8593

  Set, administration, intravascular
  1 recall2 reports
• CLEARLINK/CONTINU-FLO 2C6254

  Set, administration, intravascular
  29 reports
• CLEARLINK/CONTINU-FLO 2C8931

  Stopcock, i.V. Set
  19 reports
• CLEARLINK/CONTINU-FLO 2C6256

  Set, administration, intravascular
  17 reports
• CLEARLINK/CONTINU-FLO 1C8722

  Set, administration, intravascular
  2 reports
• CLEARLINK/CONTINU-FLO 3C0162

  Stopcock, i.V. Set
  2 reports
• CLEARLINK/CONTINU-FLO 2R8454

  Stopcock, i.V. Set
  1 report

Recent CLEARLINK/CONTINU-FLO adverse event reports

The 15 most recent reports across all models, 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 24, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889044 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875508 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757167 ↗
• 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 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 ↗
• 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 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-DEHP CONTINU-FLO SOLUTION SET LEAKED DURING AN INFUSION OF INVESTIGATIONAL DRUG XALALURITAMIG. THE PATIENT REPORTEDLY NOTED FLUID DRIPPING FROM "THE SIDE OF THE PUMP". THE INFUSION WAS SUBSEQUENTLY STOPPED, AND THE AMOUNT INFUSED WAS RECORDED BY THE REGISTERED NURSE (RN). 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 25659967 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) CONTINU-FLO SOLUTION SETS LEAKED AT THE CONNECTOR PORT. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS DURING PATIENT INFUSION. THERE WERE NO REPORTS 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 25392221 ↗

Other Baxter International Inc. products

• ONE-LINK12 models · 638 reports · 1 recall
• CLEARLINK19 models · 359 reports · 4 recalls
• INTRAVIA7 models · 455 reports
• CLEARLINK/DUO-VENT3 models · 150 reports
• INTERLINK17 models · 129 reports
• LOW RECIRCULATION VOLUME APD SET2 models · 69 reports
• Arthromatic/Uromatic3 models · 59 reports
• PrismaSATE2 models · 1 reports · 1 recall