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Medline Industries, Inc. DYNJ30263CRecalls & reported problems

Medline Industries, Inc. · FAIRFIELD CABG ACCESSARY PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489822649), received between May 31, 2022 and May 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Frayed” (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

Device problems

  • Material Frayed1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryMay 31, 2022Material Frayed

    ACCORDING TO THE FACILITY WHEN USING THE LAPAROTOMY SPONGES THE SPONGES ARE FRAYING AND GOT CAUGHT ON A CLIP ON THE LEFT INTERNAL MAMMARY ARTERY. THE FRAYED SPONGE HAD TO BE REMOVED FROM THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 14552394 ↗

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Sources and updates

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