CARDINAL HEALTH SOT30PPPR1Recalls & reported problems
Cardinal Health 200, LLC · MAYAGUEZ MC UROLOGY PACK · 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 10888439774511), received between Oct 16, 2020 and Oct 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2020Loss of or Failure to Bond
BASED ON INFORMATION FROM THE CUSTOMER THE DRAPE WAS USED EVEN THOUGH IT REPORTEDLY DID NOT STICK ON PATIENT DURING UROLOGY PROCEDURE. ALLEGEDLY THERE WAS LESS THAN A 20-MINUTE DELAY IN THE PROCEDURE WHERE THE PATIENT WAS UNDER ANESTHESIA. PER THE INFORMATION GATHERED FROM THE CUSTOMER THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10689194 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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