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ACS FHNE25ABRecalls & reported problems

American Contract Systems, Inc. · NEURO PACK · Class 1

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 00191072178213), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flaked” (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

  • Flaked1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2023Flaked; Flaked

    SURGICAL DRAPE MATERIAL IS COMING OFF. BITS OF THE MATERIAL HAVE BECOME LOOSE ON THE SURGICAL FIELD AS A RESULT. THE END USER'S HANDS AND ARMS ARE IN CONTACT WITH THE DRAPE. THE SURGEON AND OR STAFF ARE CONCERNED THAT THE DEBRIS MAY COME IN CONTACT WITH THE SURGICAL INCISION. THE SURGICAL DRAPE 13231 IS A COMPONENT OF THE ACS NUERO PACK. THE COMPLAINT SURGICAL DRAPE WAS MANUFACTURED BY O&M HALYARD INC.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16812357 ↗

Other Neurological tray devices

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Sources and updates

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