CARDINAL HEALTH SBA21PPPSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439469554), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 19, 2020Device Contamination with Chemical or Other Material

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE HAD AN INCIDENT OF AN INTERNAL INFECTION. THIS CASE USED A CARDINAL HEALTH PLASTIC PACK SBA21PPPSD WHERE A FILM-LIKE, TACKY AND GRIMY SUBSTANCE WAS PRESENT ON THE OUTSIDE OF THE STERILIZATION POUCH AND TRANSFERRED TO THE STAFF¿S HANDS. CUSTOMER STATED THEY HAVE NOT CONCLUSIVELY RULED OUT THAT THE INFECTION HAD INDEED COME FROM THE HAND PACKS. THE EVENT DATE WAS UNKNOWN. CUSTOMER WOULD NOT PROVIDE DEMOGRAPHICS OR CLINICAL DATA AFTER MULTIPLE ATTEMPTS. ALTHOUGH NO INJURY WAS REPORTED, CARDINAL HEALTH IS FILING A REPORT FOR THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 9729719 ↗