NA 2C9215Recalls & reported problems
Baxter International Inc. · Anti-Siphon Anesthesia Set, Luer Lock Adapters · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412071060), received between May 7, 2024 and Jun 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING EVALUATION OF A RETURNED ANTI-SIPHON ANESTHESIA SET, THE STERILE PACKAGING WAS FOUND TO BE "BRITTLE" (DAMAGED). NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515513 ↗MalfunctionMay 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STERILE PACKAGING OF AN UNSPECIFIED QUANTITY OF ANTI-SIPHON ANESTHESIA SETS WERE DAMAGED. THE PACKAGING APPEARED ¿BRITTLE-LIKE AND FALLS APART WHEN ATTEMPTING TO OPEN.¿ WHICH PER THE CUSTOMER ¿MADE IT IMPOSSIBLE TO PRESERVE STERILITY.¿ THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19259831 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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