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CARDINAL HEALTH SAN11EPHMERecalls & reported problems

Cardinal Health 200, LLC · STERILE EP TRAY · 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 10887488119793), received between Nov 6, 2017 and Nov 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 Protrusion/Extrusion1

Patient problems

  • Laceration(s)1

Recent adverse event reports

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

  • InjuryNov 6, 2017Material Protrusion/Extrusion

    BASED ON THE CUSTOMER INFORMATION SUBMITTED, THE STAFF MEMBER WAS CUT BY THE HALSTEAD MOSQUITO FORCEP SM161 THAT WAS STICKING THROUGH THE SURGICAL PACK. THE STAFF MEMBER WENT TO OCCUPATIONAL MEDICINE PER HOSPITAL PROCEDURE AND RECEIVED A TETANUS SHOT AS A PRECAUTIONARY MEASURE BECAUSE HE COULD NOT RECALL WHEN HE HAD HAD ONE LAST.

    Patient problems: Laceration(s)

    MAUDE report 7002862 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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