CARDINAL HEALTH SBAC2DSDCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439208214), received between Feb 18, 2020 and Mar 20, 2020 — classified as 3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2020Nonstandard Device

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE NOTICED AN INCREASE IN INFECTIONS AND BELIEVES IT¿S IN CONJUNCTION WITH THE GOWN RECALL. PATIENT HAD A LEFT HIP HEMI-ARTHROPLASTY ON (B)(6) 2019. ON (B)(6) 2019 PERSISTENT DRAINAGE. ON (B)(6) 2019 PERSISTENT DRAINAGE. ON (B)(6) 2020 PERSISTENT DRAINAGE, AND ELEVATED ESR, CRP, AND WHITE BLOOD COUNT. ON (B)(6) 2020 PATIENT DIAGNOSED WITH SEPSIS DUE TO INFECTED HEMATOMA, PATIENT WITH + TROPONINS IMMEDIATELY POST-OP. ON (B)(6) 2020 IRRIGATION AND DEBRIDEMENT OF POSTSURGICAL WOUND INCLUDING EVACUATION OF HEMATOMA. ON (B)(6) 2020 PATIENT STARTED ON VANCOMYCIN, CEFEPIME, AND LEVAQUIN WHILE INPATIENT. ON (B)(6) 2020 PATIENT DISCHARGED ON LEVOFLOXACIN 750MG ORAL DAILY FOR 7 DAYS. ON (B)(6) 2020¿PATIENT RECOVERING WELL STATUS POST LEFT HIP INFECTED HEMATOMA IRRIGATION AND DEBRIDEMENT. THIS CASE USED A CARDINAL HEALTH GENERAL SURGERY PACK SBAC2DSDCC THAT CONTAINED EITHER GOWN A9541NAE OR 90370NBA.

  Patient problems: Fluid Discharge; Hematoma; Sepsis; Unspecified Infection

  MAUDE report 9862948 ↗
• InjuryMar 20, 2020Nonstandard Device

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE NOTICED AN INCREASE IN INFECTIONS AND BELIEVES IT¿S IN CONJUNCTION WITH THE GOWN RECALL. PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. ON (B)(6) 2019 PATIENT DEVELOPED AN INFERIOR WOUND SUTURE ABSCESS, ABSCESS WAS DEBRIDED, AND PATIENT STARTED ON BACTRIM DS 800/160 MG ORAL TWO TIMES A DAY X 14 DAYS. ON (B)(6) 2019 PATIENT HAD A MILD EFFUSION ON EXAM. ON (B)(6) 2020 IRRIGATION AND DEBRIDEMENT OF LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE EXCHANGE WAS PERFORMED. ON (B)(6) 2020 PATIENT STARTED ON CEFEPIME 2 GRAMS IV EVERY 12 HOUR AS AN OUTPATIENT. (B)(6) 2020--PATIENT RECOVERING APPROPRIATELY STATUS POST LEFT TOTAL KNEE ARTHROPLASTY AND IS NOW BACK TO THIS CASE USED A CARDINAL HEALTH GENERAL SURGERY PACK SBAC2DSDCC THAT CONTAINED EITHER GOWN A9541NAE OR 90370NBA.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9862882 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE SEEN A SPIKE IN THEIR INFECTION RATES IN THE OPERATING ROOM OVER THE LAST TWO MONTHS. THIS CASE USED A CARDINAL HEALTH GENERAL SURGERY PACK SBAC2DSDCC THAT CONTAINED A LEVEL 3 SURGICAL GOWN. THE EXACT PROCEDURE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. THE PROCEDURE EITHER WAS PERFORMED PRIOR TO THE HOLD AND RECALL NOTICE(S) THAT WERE PROVIDED TO CUSTOMERS BEGINNING ON (B)(6) 2020 OR THEREAFTER. 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.

  Patient problems: Unspecified Infection

  MAUDE report 9722929 ↗