NA 2C6251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412028934), received between Aug 26, 2019 and Sep 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130245); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A FOUR-WAY LARGE BORE STOPCOCK LEAKED. THE ISSUE WAS IDENTIFIED DURING CHEMOTHERAPY INFUSION WHERE THE PATIENT REPORTED A DROP OF LIQUID ON THEIR LEG. THE INFUSION WAS STOPPED AND THE TUBING WAS INSPECTED. A CRACK WAS OBSERVED ON THE PROXIMAL SIDE OF THE LARGE BORE STOPCOCK WITH EXTENSION SET AND A SLOW DRIP OF FLUID NOTED FROM THE SITE. NO LEAK WAS OBSERVED AT THE TWO CONNECTION SITES WHERE THE PUMP TUBING FROM THE NORMAL SALINE BAG CONNECTS OR AT THE SIDE WHERE THE EQUASHIELD WAS CONNECTED. THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT WAS DONNED AND THE SET WAS CHANGED. THE PATIENT'S SKIN WAS CLEANED WITH WARM SOAPY WATER. 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 17746156 ↗
• MalfunctionAug 26, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF AN UNSPECIFIED NUMBER OF FOUR-WAY LARGE BORE STOPCOCK EXTENSION SETS WERE CUT. THE TUBING OF THE SET WAS DIAGONALLY CUT APPROXIMATELY ½ INCH. IT WAS FURTHER REPORTED THAT PROXIMAL TO THE FIRST CUT WAS ANOTHER CUT APPROXIMATELY ¼ INCH AND PROXIMAL TO THE SECOND CUT WERE TWO PARALLEL CUTS APPROXIMATELY ½ INCH EACH. THE CUTS WERE DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WERE NO INFECTION CONTROL ISSUES REPORTED AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930570 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2026 · Aug 29, 2025 · Open, Classified
  CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code