INTERLINK/CONTINU-FLO 2H6519Recalls & reported problems
Baxter Healthcare Corporation · Non-DEHP CONTINU-FLO Solution Set, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412000527), received between Sep 8, 2020 and Jan 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (1 report).
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
- Disconnection1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) NON-DEHP CONTINU-FLO SOLUTION SETS WERE NOT CONNECTING APPROPRIATELY WITH A CLOSED SYSTEM TRANSFER DEVICE END PIECE AND AN ADD-ON FILTER. THE LUER END WAS NOT FULLY LOCKING ON TO ANY ADD ON PIECES AND RESULTED IN THE SLOW LEAK DURING TREATMENT. 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 21072214 ↗MalfunctionSep 8, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE IV TUBING OF 2 NON-DEHP CONTINU-FLO SOLUTION SETS POPPED OFF AT THE SCREW-ON COLLAR. THE EVENT WAS FURTHER REPORTED AS "THE COLLAR DOES NOT ENGAGE, JUST KEEPS SPINNING AROUND AND NOT TIGHTENING". THE EVENT OCCURRED PRIOR TO ATTACHING TO THE PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10505878 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page