INTERLINK/CONTINU-FLO 3C0062Recalls & reported problems
Baxter Healthcare Corporation · CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar, Large Bore Stopcock with Rotating Male Luer Lock Extension Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00085412017716), received between Jan 29, 2019 and Oct 14, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Disconnection4
- Loose or Intermittent Connection3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS LEAKED. THE TUBING WAS NOT STAYING CONNECTED TO THE HUB WHICH CAUSED FLUID FROM THE IV (INTRAVENOUS) BAG TO LEAK. THIS OCCURRED DURING 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 20439744 ↗MalfunctionNov 30, 2021Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection; Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYTEM CONTINU-FLO SOLUTION SET LARGE BORE 4-WAY STOPCOCK EXTENSION SETS WERE LOOSE AND CAME APART AT THE STOPCOCK WHICH RESULTS IN LEAKS. THIS WAS IDENTIFIED IN THE OUT PATIENT SURGERY DEPARTMENT WHILE HOOKING UP TO IV (INTRAVENOUS) LINES. THIS WAS FURTHER DESCRIBED AS THEY ARE NOT STAYING TOGETHER ¿EVEN WHEN THEY TIGHTEN THE CONNECTION WITH AS MUCH FORCE AS THEY COULD, IT DID NOT STAY¿. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12897496 ↗MalfunctionNov 19, 2021Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection; Disconnection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SET LARGE BORE 4-WAY STOPCOCK EXTENSION SETS CAME APART AT THE STOPCOCK. ONE (1) SET FELL APART WHILE HOOKING UP THE PATIENT WHICH ALSO RESULTED IN A FLUID AND BLOOD LEAK. THE OTHER UNSPECIFIED QUANTITY OF SETS WERE ALL LOOSE AT THE STOPCOCK WHILE CHECKING THEM PRIOR TO PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849046 ↗MalfunctionNov 19, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE CONNECTION TO THE STOPCOCK OF THE UNSPECIFIED QUANTITY OF INTERLINK SYTEM CONTINU-FLO SOLUTION SETS WOULD NOT STAY. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844075 ↗MalfunctionNov 19, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTERLINK SYTEM CONTINU-FLO SOLUTION SET CAME APART AT THE STOPCOCK WHICH RESULTED IN AN INTRAVENOUS FLUID LEAK. THIS WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12844012 ↗MalfunctionJan 29, 2019Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THE FIRST PORT OF FIVE (5) INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS WAS COLLAPSED AND LEAKING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8287611 ↗
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, ClassifiedCONTINU-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
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.