CARDINAL HEALTH SANHFCLWHERecalls & reported problems
Cardinal Health 200, LLC · STEWARD ROCKLEDGE CATH RRS PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439643848), received between Oct 28, 2020 and Oct 28, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (2 reports).
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
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2020Degraded
THE CUSTOMER REPORTED NOTICING VISIBLE LINT ON THE TOWELS A COUPLE OF WEEKS AGO. THE LINT HAS GOTTEN ON DEVICES, GLOVES, DRAPES - ANYTHING THE TOWELS TOUCH. NO PATIENT DEMOGRAPHICS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748416 ↗MalfunctionOct 28, 2020Degraded
BASED ON INFORMATION RECEIVED FROM THE CUSTOMER REPORTEDLY THERE IS LINT ON TOWELS PWTB04-STM. ALLEGEDLY IT HAS GOTTEN ON DEVICES, GLOVES, DRAPES, ANYTHING THE TOWELS TOUCH. PER THE CUSTOMER, THERE WAS NO INJURY AND NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10747317 ↗
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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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