CLEARLINK/CONTINU-FLO 2C8593Recalls & reported problems
Baxter International Inc. · CONTINU-FLO Solution Set, 0.2 Micron Downstream Filter, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar · Class 2
All models of CLEARLINK/CONTINU-FLO (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412071664), received between Feb 10, 2020 and Apr 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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.
Recalls naming this device
- Aug 29, 2025Open, Classified
IV sets may leak.
Z-0196-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Backflow2
- Reflux within Device2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2020Backflow; Reflux within Device; Backflow; Reflux within Device
IT WAS REPORTED TWO (2) CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS BACKFLOWED. IT WAS OBSERVED ¿BLOOD BACKING UP TO TWO OF THE IV TUBING (UP TO THE MICRON FILTER).¿ THE IV TUBING WAS CHANGED AND BACKFLOWED OCCURRED AGAIN. THE IV TUBING WAS CHANGED AGAIN WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9930604 ↗MalfunctionFeb 10, 2020Backflow; Reflux within Device; Backflow; Reflux within Device
IT WAS REPORTED THAT THERE WAS BACKFLOW OF BLOOD FROM THE CENTRAL LINE WHILE A PATIENT WAS USING A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET. THE BACKFLOW OF BLOOD OCCURRED WHEN THE PATIENT WAS LAID ON THEIR BACK TO REPOSITION. IT WAS FURTHER REPORTED THAT THE BLOOD BACKFLOWED AWAY FROM THE PATIENT TOWARD THE LUMEN TO THE INTRAVENOUS (IV) 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 9688033 ↗
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-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 · each recall links to the FDA recall notice
- 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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