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DIATUBE002

SUNSET HEALTHCARE SOLUTIONS, INC. · Model DIATUBE002 · UDI-DI 00848530108113

GIO
10
510(k) clearances
42
Adverse events
25
Recalls
64
Facilities

Description

Sunset Capillary Tube, 15uL - 10/pack

Recalls

DateFirmReason
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.