CARDINAL HEALTH SOP2DEXDCBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885425914098), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Component” (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 18, 2020Defective Component

  CUSTOMER INFORMED CARDINAL HEALTH THAT THEY HAVE SEEN A SPIKE IN THEIR INFECTION RATES IN THE OPERATION ROOM OVER THE LAST TWO MONTHS. THIS CASE USED A CARDINAL HEALTH EXTREMITY PACK SOP2DEXDCB 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 9722815 ↗