CARDINAL HEALTH 29850Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885425501540), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Component Missing

  CUSTOMER REPORTED THAT THE 3-OZ,W/SLIM TIP, BULB, COMPONENT (B)(4), FROM THE STERILE OBSTETRICAL PACK 29850, WAS NOT INCLUDED IN THE PACK. THE PACK INCLUDED AN ASEPTO SYRINGE AND THE PRODUCT COULD NOT ASPIRATE MECONIUM DURING BIRTH OF THE INFANT. THIS CAUSED THE INFANT TO ASPIRATE AND BE PLACED IN NICU FOR 9 DAYS. INFANT REQUIRED THE USE OF A NASOGASTRIC TUBE AND PARENTERAL NUTRITION (TPN) DUE TO FLUID RETENTION. PATIENT WAS DISCHARGED AND IS CURRENTLY AT HOME IN GOOD HEALTH.

  Patient problems: Airway Obstruction; Aspiration/Inhalation; Nasal Obstruction

  MAUDE report 13501908 ↗