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CARDINAL HEALTH 09-1360BRecalls & reported problems

Cardinal Health 200, LLC · OB VAGINAL TRAY · Class 2

Data updated Oct 18, 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 10888439207811), received between Feb 4, 2019 and Feb 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionFeb 4, 2019Device Dislodged or Dislocated

    ¿DURING REPAIR OF VAGINAL DELIVERY, ROCH-PEAN CLAMP ¿POPPED OFF¿. MD STATES ¿HAD THE CLAMP BEEN PLACED ON THE FETAL SIDE OF THE UMBILICAL CORD INSTEAD OF THE MATERNAL SIDE OF THE UMBILICAL CORD THE BABY COULD HAVE BLED TO DEATH¿. MD REQUESTING FOR RADAR TO BE WRITTEN AND FDA REPORT ON DEVICE FAILURE TO BE MADE.¿

    Patient problems: No Information

    MAUDE report 8306520 ↗

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Sources and updates

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