IV Administration Set 490067Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046964186042), received between Mar 12, 2018 and Dec 13, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0645-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionDec 13, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: THE ACCOUNT USES 490067 IN THE OR AND IT IS BELIEVED THAT THE ROLLER CLAMP IS NOT WORKING PROPERLY ON THE SET. THE CUSTOMER REPORTS THAT IT HAS TO BE ROLLED DOWN COMPLETELY TO SLOW THE FLOW AND THEY ARE ENCOUNTERING PATIENTS WITH ABNORMALLY LARGE AMOUNTS OF IV FLUID ADMINISTERED. THE AMOUNT OF FLUID DOES NOT SEEM TO CORRELATE WITH THE AMOUNT OF TIME THE BAG HAS BEEN HUNG. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318049 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: THE FIRST NURSE DISCONNECTED THE IV ADMINISTRATION SET AFTER CONTINUOUS IV FLUIDS INFUSION FROM THE CARESITE VALVE EXTENSION SET EARLIER IN THE SHIFT. WHEN THE NEXT SHIFT NURSE WENT TO RECONNECT IV ADMINISTRATION SET TO CARESITE VALVE EXTENSION SET SHE SAID IT WAS DIFFICULT TO RECONNECT IT, SO THEREFORE SHE CONNECTED THE LUER ENDING TO THE CARESITE VALVE TIGHTER. LATER IN THE SHIFT, THE NURSE WENT TO DISCONNECT THE IV ADMINISTRATION SET AFTER INFUSION, AND THE LUER ENDING OF THE IV ADMINISTRATION SET BROKE OFF INTO THE CARESITE VALVE. AS A RESULT, THE VALVE WAS FORCED OPEN AND THE PATIENTS' BLOOD STARTED TO LEAK OUT OF THE VALVE. THE NURSE IMMEDIATELY HAD TO DISCONTINUE THE IV COMPLETELY, REMOVING THE IV CATHETER COMPLETELY, TO PREVENT FURTHER BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 7837114 ↗
• MalfunctionApr 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 2: AS REPORTED BY THE USER FACILITY: WHILE THE PATIENT WAS RECEIVING KVO OF NORMAL SALINE VIA GRAVITY, THE PATIENT'S BLOOD BACKED UP AND LEAKAGE OCCURRED FROM THE CARESITE VALVE ON THE EXTENSION SET. THE IV SET WAS DISCONNECTED AND THE LUER LOCK AREA APPEARED TO BE BROKEN. IT WAS STATED THAT THE ISSUE WAS WITH THE EXTENSION SET, NOT THE PRIMARY SET. NO PATIENT INJURY.

  Patient problems: Blood Loss

  MAUDE report 7430858 ↗
• MalfunctionApr 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 1: AS REPORTED BY THE USER FACILITY: WHILE THE PATIENT WAS RECEIVING KVO OF NORMAL SALINE VIA GRAVITY, THE PATIENT'S BLOOD BACKED UP AND LEAKAGE OCCURRED FROM THE CARESITE VALVE ON THE EXTENSION SET. THE IV SET WAS DISCONNECTED AND THE LUER LOCK AREA APPEARED TO BE BROKEN. IT WAS STATED THAT THE ISSUE WAS WITH THE EXTENSION SET, NOT THE PRIMARY SET. NO PATIENT INJURY.

  Patient problems: Blood Loss

  MAUDE report 7430856 ↗
• MalfunctionApr 3, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: WHILE THE PATIENT WAS RECEIVING SALINE TO KVO, LEAKAGE OCCURRED FROM THE HUB OF THE HEPLOCK SET, BETWEEN THE IV SET AND THE EXTENSION SET. THE CLINICIAN NOTICED AIR BUBBLES GOING BACK INTO THE IV SET. THE NURSE STATED THAT THE CRACK IN THE HUB ALLOWED AIR TO GET INTO THE IV SET. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393660 ↗
• MalfunctionMar 14, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: WHILE THE PATIENT WAS RECEIVING SALINE KVO, LEAKAGE OCCURRED FROM THE HUB OF THE HEPLOCK SET, BETWEEN THE IV SET AND THE EXTENSION SET. THE CLINICIAN NOTICED AIR BUBBLES GOING BACK INTO THE IV SET. THE NURSE STATED THAT THE CRACK IN THE HUB ALLOWED AIR TO GET INTO THE IV SET. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339722 ↗
• MalfunctionMar 14, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: WHILE THE PATIENT WAS RECEIVING SALINE KVO, LEAKAGE OCCURRED FROM THE HUB OF THE HEPLOCK SET, BETWEEN THE IV SET AND THE EXTENSION SET. THE CLINICIAN NOTICED AIR BUBBLES GOING BACK INTO THE IV SET. THE NURSE STATED THAT THE CRACK IN THE HUB ALLOWED AIR TO GET INTO THE IV SET. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339715 ↗
• MalfunctionMar 12, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: WHILE THE PATIENT WAS RECEIVING SALINE KVO, LEAKAGE OCCURRED BETWEEN THE EXTENSION SET AND THE IV SET. THE CLINICIAN ALSO NOTICED AIR BUBBLES GOING BACK INTO THE IV SET. THE NURSE STATED THAT THERE WAS A CRACK IN THE HUB OF THE IV SET WHICH WAS CONNECTED TO THE EXTENSION SET, AND THIS CRACK ALLOWED AIR TO GET INTO THE IV SET. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7330954 ↗
• MalfunctionMar 12, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: WHILE THE PATIENT WAS RECEIVING SALINE KVO, LEAKAGE OCCURRED BETWEEN THE EXTENSION SET AND THE IV SET. THE CLINICIAN ALSO NOTICED AIR BUBBLES GOING BACK INTO THE IV SET. THE NURSE STATED THAT THERE WAS A CRACK IN THE HUB OF THE IV SET WHICH WAS CONNECTED TO THE EXTENSION SET, AND THIS CRACK ALLOWED AIR TO GET INTO THE IV SET. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7330949 ↗