Halyard SINA214-02_0002Recalls & reported problems
Avid Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160411681), received between May 29, 2024 and May 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2024Difficult to Open or Close; Difficult to Open or Close
THE CUSTOMER REPORTED UMBILICAL CORD CLAMP REOPENED AFTER BEING CLAMPED. THIS RESULTED IN INFANT BLOOD LOSS. MEDICAL TREATMENT WAS ADMINISTERED TO STOP BLEEDING. THE INFANT IS IN GOOD STATUS, DISCHARGED FROM HOSPITAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19415615 ↗
Other Obstetrical kit devices
- Medline Industries, Inc. DYKMBNDL116GMedline Industries, Inc. · Obstetrical kit4 recalls0 reports
- Medline Industries, Inc. DYNJ58344Medline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. DYNJ67214FMedline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. CDS985431KMedline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. DYNJ42884Medline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. DYNJ906947CMedline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. DYNJ67214GMedline Industries, Inc. · Obstetrical kit3 recalls0 reports
- Medline Industries, Inc. DYNJ04135BMedline Industries, Inc. · Obstetrical kit3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page