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 ↗
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- Medline Industries, Inc. DYNJ69692Medline Industries, Inc. · General surgery tray4 recalls0 reports
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
- 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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