CARDINAL HEALTH PNVXNSLC9Recalls & reported problems
Cardinal Health 200, LLC · KIT,NEURO SPINE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594090180), received between Jul 2, 2021 and Jul 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 8, 2024Class IIOpen, Classified
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Z-1134-2025 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionJul 2, 2021Material Separation; Material Separation
CUSTOMER REPORTED THE BLUE COTTON OPERATING ROOM TOWELS PWTB04-STM FROM THE NEURO SPINE KIT PNVXNSLC9 ARE LINTING CAUSING CONCERNS FOR SURGICAL SITE INFECTIONS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE SCRUB AND DOCTORS NOTICED THE LINT ON THE INSTRUMENTS, ESPECIALLY WHEN THEY WERE WORKING UNDER THE MICROSCOPE. NO OTHER INFORMATION WAS PROVIDED WHEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12112394 ↗
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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 · each recall links to the FDA recall notice
- 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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