CLEARLINK 2C8610Recalls & reported problems
Baxter International Inc. · Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412048963), received between Apr 25, 2025 and Apr 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K112893); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 29, 2025Open, Classified
IV sets may leak.
Z-0197-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM EXTENSION SET SEPARATED FROM THE Y-SITE. THIS OCCURRED DURING INFUSION SET-UP. 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 21913366 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K112893. One submission often covers many models, so check the product and lot details in each record.
- Z-0191-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
- Z-0199-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
- Z-0190-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
- Z-0198-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
- Z-1653-2022 · Aug 9, 2022 · TerminatedBaxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
- Z-0099-2014 · Sep 4, 2013 · TerminatedBaxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation,
- Z-1271-2013 · Mar 28, 2013 · TerminatedA) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV exte
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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