CARDINAL HEALTH SAN22HCBRKRecalls & reported problems
Cardinal Health 200, LLC · STERILE HEART CATH 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 10887488265247), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 malfunction.
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
- 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.
MalfunctionDec 23, 2020Material Frayed; Material Frayed
CUSTOMER REPORTED LINTING OF BLUE TOWELS PWTB04-STM FROM THE HEART CATH TRAY PACK SAN22HCBRK ONTO INSTRUMENTS AND PATIENT DURING A CARDIAC CATHETERIZATION PROCEDURE AFFECTING THE STERILE FIELD. TOWELS WERE USED TO DRAPE PATIENT AND TO DRY HANDS OF STAFF. PATIENT DEMOGRAPHICS NOT PROVIDED UPON REQUEST. THERE WAS NO INJURY REPORTED AND PATIENT IS REPORTED AS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11065982 ↗
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- Medline Industries, Inc. DYNJ63542BMedline Industries, Inc. · Angiography/angioplasty kit2 recalls0 reports
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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