INTERLINK/CONTINU-FLO 2C6571Recalls & reported problems
Baxter Healthcare Corporation · CONTINU-FLO Solution Set, 0.2 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar · Class 2
All models of INTERLINK/CONTINU-FLO (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00085412002279), received between Dec 21, 2018 and Feb 26, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K153158); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
- Disconnection2
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
- Incomplete or Inadequate Connection1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- No Patient Involvement2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A CONTINUE-FLO SOLUTION SET HAD A FOREIGN OBJECT INSIDE THE TUBING. THIS WAS NOTICED 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 21469320 ↗MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TUBING OF A CONTINU-FLO SOLUTION SET SNAPPED AT THE JUNCTION OF THE INJECTION PORT THAT WAS CLOSEST TO THE PATIENT. 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 17925139 ↗MalfunctionFeb 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAK FROM THE JOINT OF THE TUBING TO THE MALE LUER OF A CONTINU-FLO SOLUTION SET. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION WITH REMICADE. 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 16404054 ↗MalfunctionFeb 10, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS WERE LEAKING WITH REMICADE. THE LEAK WAS COMING FROM A PIN HOLE ON THE TUBING NEAR THE SCREW END OF THE CATHETER. THIS WAS OBSERVED 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 16355161 ↗MalfunctionFeb 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE LUER OF THREE (3) CONTINU-FLO SOLUTION SETS WOULD NOT "MEET" THE HUB OF THE INTRAVENOUS (IV) CATHETER CORRECTLY DURING USE. THIS ISSUE RESULTED IN A LEAK OF DRUG MEDICATION. 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 9734259 ↗MalfunctionMay 29, 2019Disconnection; Disconnection
IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS DISCONNECTED. IT WAS FURTHER SPECIFIED THE FIXED MALE LUERS ON THE CONTINU-FLO SETS CONNECT MUCH TIGHTER TO THE THREADS ON THE ONE-LINK NEEDLE-FREE IV CONNECTOR. THE ONE-LINK HOUSING "WHICH SPRINGS THE STEM OUT OF THE COLLARS WHICH AREN'T TIGHT WHICH SEEMS IMPOSSIBLE TO TIGHTEN BECAUSE THE COLLARS ARE VERY SLOPPY WHICH MAKES THEM UNSCREW VERY EASILY HENCE LEADING TO DISCONNECTS¿. THE EVENT OCCURRED DURING INFUSION PREP IN THE PHARMACY; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8651199 ↗MalfunctionMay 28, 2019Disconnection; Disconnection
IT WAS REPORTED AN UNSPECIFIED QUANTITY OF CONTINU-FLO SOLUTION SETS DISCONNECTED. DURING AN UNSPECIFIED PROCESS STEP, THE ONE-LINKS "WERE NOT STAYING CONNECTED TO TWO TUBING SETS". 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 8645719 ↗MalfunctionDec 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN INTERLINK CONTINU-FLO SOLUTION ADMINISTRATION SET HAD A FOREIGN OBJECT INSIDE THE TUBING. THE EVENT WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8190136 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.
- Z-0196-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
- Z-0195-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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