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CONVERTORS AT71021Recalls & reported problems

Cardinal Health 200, LLC · Insta-Gard Procedure Mask, Blue · Class 2

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 20885380072014), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Anaphylactic Shock1
  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

  • InjuryMar 23, 2018Patient-Device Incompatibility

    NURSE SOUGHT TREATMENT FROM SHORELINE ALLERGY STATING SHE HAD HAD AN ANAPHYLACTIC REACTION TO THE MASK. SHORELINE ALLERGY CONTACTED CARDINAL HEALTH FOR MASK INGREDIENTS. THEY STATE NURSE IS DOING FINE.

    Patient problems: Anaphylactic Shock; Hypersensitivity/Allergic reaction

    MAUDE report 7365433 ↗

Other Mask, surgical devices

All Mask, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.