ICU Medical VB-20Recalls & reported problems
Icu Medical, Inc. · Rio™ Drug Reconstitution Transfer Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709120594), received between Dec 19, 2023 and Jan 12, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material4
- Fluid/Blood Leak1
- No Flow1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Device Contamination with Chemical or Other Material
AN EVENT INVOLVED A RIO TRANSFER DEVICE STATED THAT THE DEVICE HAS BLACK HAIRS ALONG BLUE SPIKE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM / INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050184 ↗MalfunctionJan 12, 2026Device Contamination with Chemical or Other Material
THE EVENT INVOLVED A RIO TRANSFER DEVICES WHERE IT WAS REPORTED THAT THE DEVICE HAD "BLACK SPECS" ALONG SPIKE AND "BLACK STRING UNDER WHITE CAP". THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 13 INCIDENTS WITH NO OTHER IDENTIFYING INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037489 ↗MalfunctionDec 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A COMPLAINT WAS RECEIVED REGARDING TO A RIO TRANSFER DEVICES IN WHICH IT WAS REPORTED THAT THE DEVICE HAVE FLOATING PARTICLES AND ¿HAIR LIKE¿ SUBSTANCE ON THE DEVICE WHEN OPENED FROM PACKAGE UPON INSPECTION. NO PATIENT INVOLVEMENT AND NO HARM WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888551 ↗MalfunctionDec 24, 2025Particulates; Device Contamination with Chemical or Other Material; Particulates; Device Contamination with Chemical or Other Material
UPDATED INFORMATION RECEIVED STATING THE DEVICE HAD FLOATING PARTICLES AND ¿HAIR LIKE¿ SUBSTANCE ON THE DEVICE WHEN OPENED FROM PACKAGE UPON INSPECTION. NO PATIENT INVOLVEMENT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887907 ↗MalfunctionJan 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THAT ON AN UNKNOWN DATE, A RIO¿ DRUG RECONSTITUTION TRANSFER DEVICE WAS FOUND TO HAVE LEAKED DURING PATIENT USE. THE REPORT STATES THAT THE "PRIMARY RN ATTEMPTED TO ADMINISTER IV MEROPENEM USING RIO DEVICE, HOWEVER SIGNIFICANT AMOUNT OF LEAKING AROUND DEVICE WHERE IT ATTACHES TO SALINE BAG OCCURRED EACH TIME. THE RN ATTEMPTED 3 TIMES WITH ALL NEW SUPPLIES EACH TIME." THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21280369 ↗MalfunctionDec 19, 2023No Flow; No Flow
ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON DECEMBER 21, 2023, STATING THE EVENT OCCURRED DURING COMPOUNDING - WHILE PREPARING TO ATTACH A VIAL TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358751 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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