INTERLINK/CONTINU-FLO/CONTROL-A-FLO 2C6895Recalls & reported problems
Baxter International Inc. · CONTINU-FLO Solution Set with CONTROL-A-FLO Regulator, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar · Class 2
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 00085412004037), received between Mar 8, 2019 and Apr 3, 2019 — classified as 2 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
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionApr 3, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE DISTAL TUBING OF AN INTERLINK CONTINU-FLO SET DISCONNECTED FROM THE CONTROL-A-FLO REGULATOR. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 8478601 ↗MalfunctionMar 8, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE DISTAL END OF THE TUBING OF AN INTERLINK SYSTEM CONTINU-FLO SOLUTION SET WITH CONTROL-A-FLO REGULATOR BECAME DISCONNECTED FROM THE FLOW REGULATOR. IT WAS FURTHER REPORTED THAT ¿IT LOOKED LIKE THERE WAS NO ADHESIVE BOND AT ALL¿. THIS EVENT OCCURRED DURING THERAPY. 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 8404827 ↗
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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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