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Regard™ 303403Recalls & reported problems

Resource Optimization & Innovation, L.L.C. · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Feb 28, 2022Terminated

    A kit component, the PDI Prevantics Swab, was recalled.

    Z-0950-2022 · Root cause: Process control · FDA record ↗

Other I.V. Start Kit devices

All I.V. Start Kit devices →

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