McKesson 25-2835Recalls & reported problems
Mckesson Medical-Surgical Inc. · DRESSING CHANGE TRAY, CTRL LIN · Class 2
Data updated Oct 16, 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 10612479182483), received between Sep 3, 2021 and Sep 3, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination 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 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination 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.
MalfunctionSep 3, 2021Contamination /Decontamination Problem
MY NURSE OPENED THE MCKESSON DRESSING CHANGE TRAY CVC PACKAGE AND AS WE PULLED OUT THE STERILE FIELD A DEAD BUG FELL OUT FROM INSIDE THE STERILE FIELD DRAPE. THE STERILE PACKAGE SEALS WERE INTACT WITH NO EVIDENCE OF DAMAGE TO THE PACKAGE OR CONTENTS. LOT #282645. EXPIRATION 2023-08-05. MFR #25-2835. FORTUNATELY AN ADDITIONAL DRESSING CHANGE KIT WAS AVAILABLE AND USED DUE TO SUSPECTED COMPROMISE OF CLEANLINESS AND STERILITY OF PACKAGE MATERIALS. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12432748 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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