CARDINAL HEALTH SBA16BASHKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439350579), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryFeb 21, 2020Contamination; Nonstandard Device

  CUSTOMER INFORMED CARDINAL HEALTH THAT APPROXIMATELY A WEEK AFTER INFRAMAMMARY BREAST AUGMENTATION, A FEMALE PATIENT DEVELOPED REDNESS OF BOTH LOWER BREASTS WITHOUT FEVER WHERE SUCH REDNESS IS EXTREMELY UNUSUAL. DOCTOR WAS UNABLE TO CULTURE BREASTS SINCE IT WOULD REQUIRE GOING BACK TO SURGERY, SO PATIENT WAS STARTED ON ANTIBIOTICS. THE COURSE OF ANTIBIOTICS WAS LENGTHENED BY INFECTIOUS DISEASE DOCTOR. CUSTOMER IS WONDERING IF THIS ISSUE IS IN CONJUNCTION WITH THE GOWN RECALL. THIS CASE USED A CARDINAL HEALTH BREAST AUGMENTATION PACK SBA16BASHK THAT CONTAINED AAMI LEVEL 3 GOWN 9548NCB AND 9518NCB. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND A WORK ORDER/LOT NUMBER WAS NOT PROVIDED FOR THE KIT, THEREFORE, WE ARE UNABLE TO CONFIRM THAT THE GOWN IN THE KIT WAS PART OF THE RECALL ISSUED BY CARDINAL HEALTH. THE PATIENT IS NOW FINE WITH NO SIGNS OF INFECTION

  Patient problems: Erythema

  MAUDE report 9742187 ↗