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CARDINAL HEALTH PN08CPPCARecalls & reported problems

Cardinal Health 200, LLC · KIT, CRANIOTOMY PMH · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jul 14, 2026Open, Classified

    Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

    Z-2945-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

  2. Nov 8, 2024Open, Classified

    Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

    Z-0915-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Other Neurological tray devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.