CARDINAL HEALTH SBA56GPIHMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488722580), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionFeb 26, 2020Material Puncture/Hole

  WHILE DRAPING THE PATIENT, THE SCRUB TECH DISCOVERED A HOLE IN THE LAP CHOLECYSTECTOMY DRAPE THAT WAS PROVIDED IN THE GEN PACK UCR #SBAGPIHM LOT#334264 EXP.2024-03-01. THERE WAS NO INCISION MADE ON THE PATIENT AT THIS TIME AND WE DISCARDED ALL SUPPLIES ON THE BACK TABLE AND MAYO STAND WITHOUT USING ANY SUPPLIES ON THE PATIENT. THE HOLE APPEARED TO BE A MANUFACTURER DEFECT OF THE DRAPE AND NOT A HOLE THAT WOULD HAVE BEEN PUNCTURED BY AN OBJECT. THE DRAPE WAS SAVED FOR RISK MANAGEMENT ALONG WITH THE PACK CONTENTS SHEET WITH THE LOT #, ETC ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9752990 ↗