CARDINAL HEALTH SAN22CPBM3Recalls & reported problems
Cardinal Health 200, LLC · CATH 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 10888439444476), received between Jun 11, 2019 and Jun 11, 2019 — 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2019Material Frayed
THE CUSTOMER REPORTED LINTING OF THE BLUE NON-XRAY TOWELS (B)(4) FROM THE CATHETERIZATION KIT SAN22CPBM3. NO DETAILED COMPLAINT INFORMATION, PATIENT DEMOGRAPHICS OPERATING ROOM CLINICAL DATA WAS PROVIDED AFTER MULTIPLE ATTEMPTS TO RETRIEVE FROM CUSTOMER. THERE WAS NO PATIENT INJURY REPORTED. AN MDR IS BEING FILED BASED ON POTENTIAL RISK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8687069 ↗
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- Medline Industries, Inc. DYNJ40632CMedline Industries, Inc. · Angiography/angioplasty kit2 recalls1 report
- Merit Medical® 00884450140840Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- Merit Medical® 00884450140796Merit Medical Systems, Inc. · Angiography/angioplasty kit2 recalls0 reports
- 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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