CARDINAL HEALTH SNE13CR602Recalls & reported problems
Cardinal Health 200, LLC · CRANIOTOMY PACK · 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 10197106862094), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
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.
MalfunctionApr 23, 2025Contamination
FROM STAFF: IN THE LAST TWO DAYS, WE HAVE DISCOVERED A TOTAL OF 15 CARDINAL SURGICAL PACKS THAT HAD FOREIGN OBJECTS IN SOME PART OF THE PACK. THESE PACKS WERE ALL DEEMED AS CONTAMINATED. THE TYPE OF PACKS ARE SPINE PACKS, LOWER EXTREMITY PACK, CRANIOTOMY PACK AND ARTHROSCOPY PACK. AT TIMES, WE OPENED MULTIPLE OF THE SAME PACKS ONLY TO FIND THAT EACH OF THEM WAS CONTAMINATED. DUE TO THIS, WE STOPPED OPENING PACKS IN HOPES OF FINDING ONE NOT CONTAMINATED AND INSTEAD HAD SPD [STERILE PROCESSING DEPARTMENT] STERILE CORE JUST PICK THE SINGLE STERILE ITEMS THAT WOULD OTHERWISE BE IN THE PACK. THIS DELAYED US SIGNIFICANTLY. OF PARTICULAR NOTE IS THAT DURING SETUP FOR AN EMERGENT CLASS A CRANIOTOMY THIS MORNING, WE OPENED FOUR PACKS THAT WERE DEEMED CONTAMINATED. DUE TO THIS CASE BEING TIME CRITICAL, WE MOVED TO PICKING INDIVIDUAL STERILE SUPPLY ITEMS FOR THE CASE. SOME OF THE ITEMS DEEMED CONTAMINATED WERE THROWN OUT BUT SOME HAVE BEEN RETAINED BY THE OPERATING ROOM. MANUFACTURER RESPONSE FOR ARTHROSCOPY PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER). REPS [REDACTED] AND [REDACTED] HAVE BEEN MADE AWARE. ON SITE [REDACTED] AND [REDACTED]. MANUFACTURER RESPONSE FOR NEUROLOGICAL TRAY, CARDIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890507 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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