INTERLINK/CONTINU-FLO 2C6931Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412035475), received between Jan 29, 2019 and Nov 6, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE LUER CONNECTION OF AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS COULD NOT BE TIGHTENED. THIS WAS IDENTIFIED DURING UNSPECIFIED PROCESS STEPS PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10801106 ↗
• MalfunctionOct 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO TIGHTEN THE LUER CONNECTION ON AN INTERLINK SYSTEM CONTINU-FLO SOLUTION SET. THIS WAS IDENTIFIED DURING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10708354 ↗
• MalfunctionApr 20, 2020Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER THAT CONNECTS TO THE MANIFOLD AND THE MALE LUER LOCK OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SET WOULD NOT TIGHTEN. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9979417 ↗
• MalfunctionApr 6, 2020Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER COLLAR THAT CONNECTS TO THE MANIFOLD AND THE MALE LUER LOCK OF AN UNSPECIFIED NUMBER OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS WOULD NOT TIGHTEN AND ¿FALLS APART¿. THIS WAS FURTHER DESCRIBED AS, UPON REMOVAL OF THE ¿ANESTHESIA IV (INTRAVENOUS) SET FROM ITS PACKAGING, THE NURSE TIGHTENS ALL CONNECTORS AT THE MANIFOLD OR STOPCOCK¿. SUBSEQUENTLY, THE LUER COLLAR DOES NOT TIGHTEN DOWN AT THE MANIFOLD CONNECTION AND IT ¿FREQUENTLY FALLS APART¿. ALSO, THE MALE LUER LOCK DOES NOT SCREW INTO THE INTRAVENOUS (IV) CATHETER HUB; FURTHER DESCRIBED AS, "THE LUER LOCK IS SEIZED IN PLACE AND THEY CANNOT SCREW IT DOWN TO THE IV HUB". THIS REQUIRES A NEW SET TO BE OBTAINED. 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 9930858 ↗
• MalfunctionApr 6, 2020Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LUER COLLAR THAT CONNECTS TO THE MANIFOLD AND THE MALE LUER LOCK OF AN UNSPECIFIED NUMBER OF INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS WOULD NOT TIGHTEN AND ¿FALLS APART¿. THIS WAS FURTHER DESCRIBED AS, UPON REMOVAL OF THE ¿ANESTHESIA IV (INTRAVENOUS) SET FROM ITS PACKAGING, THE NURSE TIGHTENS ALL CONNECTORS AT THE MANIFOLD OR STOPCOCK¿. SUBSEQUENTLY, THE LUER COLLAR DOES NOT TIGHTEN DOWN AT THE MANIFOLD CONNECTION AND IT ¿FREQUENTLY FALLS APART¿. ALSO, THE MALE LUER LOCK DOES NOT SCREW INTO THE INTRAVENOUS (IV) CATHETER HUB; FURTHER DESCRIBED AS, "THE LUER LOCK IS SEIZED IN PLACE AND THEY CANNOT SCREW IT DOWN TO THE IV HUB". THIS REQUIRES A NEW SET TO BE OBTAINED. 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 9930794 ↗
• MalfunctionFeb 5, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK CONNECTOR OF AN INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD SET ¿FALLS APART AFTER TIGHTENING¿ (DISCONNECTS). IT WAS FURTHER REPORTED THAT THE LUER LOCK COULD NOT BE FINGER TIGHTENED AND AS A RESULT, THE ¿LUER LOCK-FALLS APART EVEN AFTER PUSHING SLIP TIP IN AND TWISTING.¿ THIS WAS IDENTIFIED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9673583 ↗
• MalfunctionFeb 4, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE LUER LOCK/SLIP TIP CONNECTOR OF TWO (2) INTERLINK SYSTEM CONTINU-FLO SOLUTION SETS FALLS APART. IT WAS FURTHER REPORTED THAT THE LUER LOCK WAS UNABLE TO BE FINGER TIGHTENED. THIS ISSUE WAS IDENTIFIED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9665323 ↗
• MalfunctionJan 29, 2019Connection Problem; Connection Problem

  THIS REPORT SUMMARIZES MALFUNCTION EVENTS. IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD SETS HAD CONNECTION ISSUES. THE REPORTER STATED THAT THE MANIFOLD WOULD NOT TIGHTEN ONTO THE LUER LOCK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286694 ↗
• MalfunctionJan 29, 2019Disconnection; Disconnection

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF INTERLINK CONTINU-FLO MULTI-PORT MANIFOLD SETS DISCONNECTED AFTER TIGHTENING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286669 ↗