INTERLINK/CONTINU-FLO 2C6537Recalls & reported problems
Baxter Healthcare Corporation · CONTINU-FLO Solution Set, 3 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412002248), received between Apr 18, 2019 and Jul 1, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 reports).
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.
Most reported problems
Device problems
- Disconnection2
- Fluid/Blood Leak1
- Material Deformation1
- No Flow1
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING OF CONTINU-FLO SOLUTION SET FELL APART AND CAME OUT OF THE CANNULA WHEN ATTEMPTING TO REMOVE THE TIP PROTECTOR. THIS RESULTED IN A WASTE OF IMMUNOGLOBULIN IN THE TUBING. 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 10218694 ↗MalfunctionDec 17, 2019Disconnection; Disconnection
IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET HAD A DISCONNECTION ISSUE. IT WAS FURTHER REPORTED THE LUER END OF THE TUBING CAME OFF WITH THE CAP. THIS ISSUE WAS IDENTIFIED DURING CAP REMOVAL, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9484642 ↗MalfunctionApr 18, 2019Material Deformation; No Flow; Material Deformation; No Flow
IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET WOULD NOT PRIME DUE TO A KINKED TUBING. THIS EVENT WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8527136 ↗
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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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