CARDINAL HEALTH SBA56PUIMBRecalls & reported problems
Cardinal Health 200, LLC · PACK URO CYSTO IHC · 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 10888439446616), received between Aug 6, 2019 and Aug 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2019Device Contamination with Chemical or Other Material
THE CAREGIVER OPENED THE CYSTO PACK FOR A CASE AND SAW A PIECE OF SOMETHING ON THE PACK. IT WAS SEEN RIGHT AWAY AND NOTHING ELSE WAS CONTAMINATED. THERE WAS NO HARM CAME TO THE PATIENT. IT LOOKED LIKE A CRUMB OR A SMALL ROCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8864231 ↗
Other Endoscope introducer kit devices
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- Medline Industries, Inc. DYNJ66447Medline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- Medline Industries, Inc. DYNJ58648JMedline Industries, Inc. · Endoscope introducer kit2 recalls0 reports
- ACS BUCY78EAmerican Contract Systems, Inc. · Endoscope introducer kit2 recalls0 reports
- ACS LVCY20AAmerican Contract Systems, Inc. · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH PGVMDVB26Cardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH SOT51CPKOACardinal Health 200, LLC · Endoscope introducer kit1 recall0 reports
- CARDINAL HEALTH PGOCRDNHDCardinal Health 200, LLC · Endoscope introducer kit1 recall0 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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