CARDINAL HEALTH SOP21HPPSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439440010), received between Feb 19, 2020 and Feb 27, 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.

• InjuryFeb 27, 2020Nonstandard Device

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE NOTICED AN INCREASE IN INFECTIONS AND BELIEVES IT¿S IN CONJUNCTION WITH THE GOWN RECALL. THIS CASE USED A CARDINAL HEALTH HAND PACK SOP21HPPSF THAT CONTAINED AN AAMI LEVEL 3 GOWN 9545NCC AND 90270NBA. GOWN 9545NCC AND 90270NBA WERE NOT PART OF THE RECALL. THE PROCEDURE WAS PERFORMED PRIOR TO THE HOLD AND RECALL NOTICE(S) THAT WERE PROVIDED TO CUSTOMERS BEGINNING ON 1/12/2020. PROCEDURE PERFORMED WAS A LEFT CARPAL TUNNEL RELEASE WHERE THE PATIENT DEVELOPED A SURGICAL SITE INFECTION DIAGNOSED IN A POST-SURGICAL OFFICE VISIT. THE PATIENT¿S INFECTION IS NOW HEALED.

  Patient problems: Unspecified Infection

  MAUDE report 9760266 ↗
• InjuryFeb 21, 2020Nonstandard Device

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE NOTICED AN INCREASE IN INFECTIONS AND BELIEVES IT¿S IN CONJUNCTION WITH THE GOWN RECALL. THIS CASE USED A CARDINAL HEALTH HAND PACK SOP21HPPSF THAT CONTAINED AN AAMI LEVEL 3 GOWN 9545NCC. GOWN 9545NCC WAS NOT PART OF THE RECALL. THE PROCEDURE WAS PERFORMED PRIOR TO THE HOLD AND RECALL NOTICE(S) THAT WERE PROVIDED TO CUSTOMERS BEGINNING ON 1/12/2020. PROCEDURE PERFORMED WAS A LEFT CARPAL TUNNEL RELEASE WHERE THE PATIENT DEVELOPED A SURGICAL SITE INFECTION DIAGNOSED IN A POST-SURGICAL EMERGENCY ROOM VISIT. PATIENT IS NOW HEALED.

  Patient problems: Unspecified Infection

  MAUDE report 9741476 ↗
• InjuryFeb 19, 2020Device Contamination with Chemical or Other Material

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE HAD AN INCIDENT OF AN INTERNAL HAND INFECTION. THIS CASE USED A CARDINAL HEALTH HAND PACK SOP21HPPSF 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 9729605 ↗