CARDINAL HEALTH SANHDPCRVGRecalls & reported problems
Cardinal Health 200, LLC · PORT O 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 10888439158441), received between Feb 12, 2019 and Feb 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
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.
MalfunctionFeb 12, 2019Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT FIBERS FROM THE BLUE OR TOWELS PWTB03-STMA ARE COMING IN THE PORT O CATHETER PACK/ SANHDPCRVG AND WERE FOUND ON THE GLOVES OF THE STAFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS OR ADDITIONAL QUALIFYING INFORMATION WOULD BE PROVIDED BY THE CUSTOMER. THE MDR WILL BE FILED FOR MALFUNCTION AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8332853 ↗
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- ACS UIPO82ABAmerican Contract Systems, Inc. · Port introducer kit1 recall0 reports
- ACS UIPP76KAmerican Contract Systems, Inc. · Port introducer kit1 recall0 reports
- Regard™ GS0348Resource Optimization & Innovation, L.L.C. · Port 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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