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CARDINAL HEALTH SBA73BRAMARecalls & reported problems

Cardinal Health 200, LLC · STERILE GENERAL BREAST PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885425387274), received between Feb 26, 2020 and Feb 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

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.

Most reported problems

Device problems

  • Nonstandard Device2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bacterial Infection1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 26, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER ALLEGEDLY A PATIENT HAD AN INFECTION, ON (B)(6) 2019. THE INFECTION WAS CALLED NON-TB ATYPICAL MICROBACTERIA. REPORTEDLY THE HEALTH DEPARTMENT CAME IN AND DID A THOROUGH TESTING AND FOUND NOTHING. THE CUSTOMER PROVIDED NO FURTHER INFORMATION AFTER SEVERAL ATTEMPTS.

    Patient problems: Unspecified Infection

    MAUDE report 9759201 ↗
  • InjuryFeb 26, 2020Nonstandard Device

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER ALLEGEDLY A PATIENT HAD AN INFECTION, ON (B)(6) 2019. THE INFECTION WAS CALLED NON-TB ATYPICAL MICROBACTERIA. REPORTEDLY THE HEALTH DEPARTMENT CAME IN AND DID A THOROUGH TESTING AND FOUND NOTHING. THE CUSTOMER PROVIDED NO FURTHER INFORMATION AFTER SEVERAL ATTEMPTS.

    Patient problems: Bacterial Infection

    MAUDE report 9759097 ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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