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CONVERTORS 9041 (UDI 10885380156069)Recalls & reported problems

Cardinal Health 200, LLC · SmartSleeve Surgical Gown, XL. Polyreinforced Surgical Gown · Class 2

All models of CONVERTORS (38)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380156069), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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 16, 2026.

Most reported problems

Device problems

  • Therapeutic or Diagnostic Output Failure1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 23, 2020Therapeutic or Diagnostic Output Failure

    CUSTOMER REPORTED STRIKETHROUGH OF GOWN TO PHYSICIAN¿S ARMS DURING A DIAGNOSTIC LAPAROSCOPY AND LAPAROTOMY ADHESIOLYSIS W/ LAVAGE CHOLECYSTECTOMY FOR PERFORATED GALLBLADDER. THERE WAS NO REPORTED INJURY TO PHYSICIAN OR PATIENT DUE TO STRIKETHROUGH. IT WAS REPORTED THAT MEROPENEM 1G IN .09% SODIUM CHLORIDE 50ML MBP WAS GIVEN TO THE PATIENT AT THE BEGINNING OF THE SURGERY FOR THE PERFORATED GALLBLADDER INFECTION RISK SO NO ADDITIONAL ANTIBIOTICS WERE LATER NEEDED DUE TO THE STRIKETHROUGH. NO DEMOGRAPHICS PROVIDED. MDR BEING FILED FOR POTENTIAL RISK TO PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10318181 ↗

Other GOWN, SURGICAL devices

All GOWN, SURGICAL devices →

Sources and updates

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