INTERLINK 2H6401Recalls & reported problems
Baxter Healthcare Corporation · Non-DEHP Solution Set, Injection Site, Lever Lock Cannula, Male Luer Lock Adapter with Retractable Collar · Class 2
- 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 00085412068190), received between Oct 15, 2024 and Mar 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF INTERLINK NON-DEHP SOLUTION SETS HAD CONNECTION ISSUES WITH CLEARLINK SYSTEM EXTENSION SETS. THE RETRACTABLE COLLAR DID NOT STAY ENGAGED UPON CONNECTION; THE RING THAT LOCKS IN PLACE WOULD "UNSCREW". THIS WAS DISCOVERED DURING USE; HOWEVER, PATIENT INVOLVEMENT WAS NOT SPECIFIED. 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 21702315 ↗MalfunctionOct 15, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK NON DEHP BASIC SETS LUER LOCK ADAPTER WAS UNABLE TO CONNECT TO THE FEMALE CONNECTION POINTS. THE MALE TIP FITS INTO THE FEMALE CONNECTION POINTS; HOWEVER, THE SPINNING LUER-LOCK DOES NOT TIGHTEN. THIS OCCURRED 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 20457812 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.