CARDINAL HEALTH SMA56DBIHFRecalls & reported problems
Cardinal Health 200, LLC · PACK OB VAG DEL BASIN 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 10887488814766), received between Mar 20, 2020 and Mar 20, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
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.
MalfunctionMar 20, 2020Component Missing
ANESTHESIA MONITORING TECH OPENED THE "PACK OB VAG DEL BASIN IHC" PACK FOR AN OB VAGINAL DELIVERY AND IT WAS MISSING THE PACK OF SPONGES. NORMALLY THERE ARE 5 SPONGES PACKAGED IN THE PACK. THE TECH OBTAINED AN ADDITIONAL PACK OF SPONGES TO ADD TO THE DELIVERY TABLE TO USE WITH THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9859763 ↗
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- Medline Industries, Inc. DYNJ901387AMedline Industries, Inc. · Labor and Delivery Kit2 recalls1 report
- Medline Industries, Inc. DYNJ47625BMedline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Medline Industries, Inc. PAIN1699AMedline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Medline Industries, Inc. DYNJ68663Medline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Centurion MNS8950ACenturion Medical Products Corporation · Labor and Delivery 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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