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Kerlix 4037Recalls & reported problems

Cardinal Health, Inc. · X-Ray Detectable Laparotomy Sponges,Tray Pack · Class 1

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 10884527020843), received between Dec 30, 2019 and Dec 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Misassembled During Manufacturing /Shipping1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 30, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

    THE CUSTOMER REPORTED THAT AT THE TIME OF OPENING THE TRAYS, THEY REALIZED THAT INSTEAD OF FIVE UNITS PER TRAY THERE WERE SIX.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9531763 ↗

Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices

All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.