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Cook G20899Recalls & reported problems

Cook Incorporated · Maximal Sterile Barrier Bedside Tray · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002208995), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 injury.

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

  • Fracture1
  • 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.

  • InjuryJun 9, 2021Fracture; Material Separation; Fracture; Material Separation

    IN ADDITIONAL INFORMATION PROVIDED 28JUN2021, IT WAS REPORTED THAT THE DEVICE WAS IN PLACE FOR ONE WEEK PRIOR TO THE COMPLAINT EVENT. THE DEVICE WAS USED WITH POWER INJECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11968619 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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