IV3000 6X8.5CM-CARTON OF 10 4924Recalls & reported problems
Smith & Nephew Medical Limited · Moisture responsive IV catheter dressing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223422097), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (1 report).
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.
Most reported problems
Device problems
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2022Separation Problem; Separation Problem
IT WAS REPORTED THAT AN IV3000 6X8.5CM CTN 100 INFUSION SET TAPE IS UNMANAGEABLE AS THE THIN TOP PIECE OF TAPE COVERING DOES NOT PEEL OFF EASILY. AS WELL, THE TAPE GETS WRINKLED AND STARTS TO PEEL OFF AFTER BATHING. SKIN TAC OR ADDITIONAL STRIPS OF ANOTHER TAPE HAD TO BE USED. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13584867 ↗
Other Tape And Bandage, Adhesive devices
- IV3000-1-HAND 10X12CM-CARTON OF 50 66024008Smith & Nephew Medical Limited · Tape And Bandage, Adhesive62 reports
- CURAD NON25600QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall2 reports
- IV3000-1-HAND 6X7CM-CARTON OF 100 66024007Smith & Nephew Medical Limited · Tape And Bandage, Adhesive52 reports
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- CURAD NON256133QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- CURAD NON25660QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- Seer Home SM-01-9005Seer Medical Holdings Limited · Tape And Bandage, Adhesive1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page