CARDINAL HEALTH SOP54PYPTARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488375717), received between Feb 11, 2020 and Feb 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED, ¿WE ARE CURRENTLY TRACKING INFECTION FROM A CASE THAT OCCURRED ON (B)(6) 2019 AND QUALITY ISSUE RELATED TO THE MANUFACTURE OF CERTAIN AAMI LEVEL 3 SURGICAL GOWN.¿ CUSTOMER HAS REPORTED THE PROCEDURE WAS A LEFT FOOT BUNIONECTOMY, OSTEOTOMY OF SECOND AND THIRD METATARSALS, SECOND AND THIRD AND FOURTH ARTHROPLASTY PIJ LEFT FOOT, AND PLANTAR PLATE REPAIR. THE MEDICAL TREATMENT PROVIDED FOR THE INFECTION WAS URGENT CARE VISIT, HOSPITALIZATION, ORAL AND IV ANTIBIOTIC THERAPY, RETURN TO SURGERY FOR I&D, REMOVAL OF IMPLANTS. INSERTION OF PICC LINE BY HOME HEALTH CARE. THE PRESCRIPTIVE MEDICATION FOR THE PATIENT IS PO (ORAL) AUGMENTIN, IV ANTIBIOTICS AS WELL BUT THE EXACT ANTIBIOTIC GIVEN WAS NOT NOTED ON THE PHYSICIAN OFFICE RECORD. AS OF (B)(6) 2020, PATIENT WAS RECEIVING HOME HEALTH CARE AND IV ANTIBIOTICS VIA PICC LINE.

  Patient problems: Unspecified Infection

  MAUDE report 9708632 ↗
• InjuryFeb 11, 2020Nonstandard Device

  CUSTOMER INFORMED CARDINAL THAT THEY ARE TRACKING A PATIENT WITH AN INFECTION FROM A CASE THAT OCCURRED ON (B)(6) 2019. THIS CASE USED A CARDINAL HEALTH PODIATRY PACK THAT CONTAINED A LEVEL 3 SURGICAL GOWN. THE PROCEDURE WAS PERFORMED PRIOR TO THE HOLD AND RECALL NOTICE(S) THAT WERE PROVIDED TO CUSTOMERS BEGINNING ON (B)(6) 2020. 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 9696262 ↗