CLR1 - CLEARLINK 2R8402Recalls & reported problems
Baxter International Inc. · Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 100” (2.5m) approx., 10 drops/mL approx. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412676623), received between Feb 1, 2022 and Aug 20, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).
6 other recalls cover devices cleared under the same FDA submission (K180739); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak10
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED BETWEEN THE TUBING AND THE DRIP CHAMBER. THIS OCCURRED 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 20006921 ↗MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED WHERE THE BURETROL MEETS THE IV TUBING. THIS OCCURRED DURING TPN (TOTAL PARENTERAL NUTRITION) 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 18788649 ↗MalfunctionFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TUBING OF TWO (2) CLEARLINK SYSTEM NON-DEHP SOLUTION SETS HAD LEAKED AT THE JUNCTION "WHERE THE BURETROL MEETS THE IV TUBING". THIS OCCURRED DURING TOTAL PARENTERAL NUTRITION (TPN) 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 18773159 ↗MalfunctionDec 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED AT THE JUNCTION OF DRIP CHAMBER AND TUBING. THIS OCCURRED 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 18296554 ↗MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CLEARLINK SYSTEM SOLUTION SET WAS LEAKING FROM THE DRIP CHAMBER WHICH RESULTED IN AIR IN THE LINE. THIS EVENT OCCURRED 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 18277147 ↗MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED TOTAL PARENTERAL NUTRITION BELOW THE DRIP CHAMBER. THIS WAS DISCOVERED 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 17504057 ↗MalfunctionMay 3, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CLEARLINK SYSTEM NON-DEHP SOLUTION SET WAS DRIPPING AND LEAKING BELOW THE DRIP CHAMBER. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. 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 14271602 ↗MalfunctionApr 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET LEAKED. THE EVENT OCCURRED DURING AN UNKNOWN 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 14036320 ↗MalfunctionFeb 1, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET APPEARED CRACKED AND SUBSEQUENTLY LEAKED. THE EVENT OCCURRED IN THE NEONATAL ICU DURING TOTAL PARENTERAL NUTRITION (TPN) INFUSION. THE TPN WAS DISCARDED. 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 13416904 ↗MalfunctionFeb 1, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THE TUBING OF A CLEARLINK SYSTEM NON-DEHP SOLUTION SET APPEARED CRACKED AND SUBSEQUENTLY LEAKED. THE EVENT OCCURRED IN THE NEONATAL ICU DURING TOTAL PARENTERAL NUTRITION (TPN) INFUSION. THE TPN WAS DISCARDED. 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 13416903 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180739. One submission often covers many models, so check the product and lot details in each record.
- Z-0201-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK 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, ClassifiedCLEARLINK 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-0202-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
- Z-1010-2025 · Dec 20, 2024 · Open, ClassifiedBaxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
- Z-1009-2025 · Dec 20, 2024 · Open, ClassifiedBaxter Solution Set with Duo-Vent Spike, REF 2R8404
- Z-1291-2024 · Feb 8, 2024 · Open, ClassifiedCLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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