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Recall Observatory FDA recall evidence

Device product

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube

Z-0558-2026

September 26, 2025

Class II

Product summary

Firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Event
Event 97592
Status
Ongoing
Classification
Class II
Quantity
352750
Official record key
device-enforcement:Z-0558-2026

Official wording

Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

Code information: Model Number: 06 0187 GTIN (Inner Pack): 30643351000285 UDI-DI: 10643351000281 All Lots produced from 31JUL2023 to 28FEB2025: 23I4063, 24A4108, 24B4197, 24D4023, 24E4137, 24E4278, 24L4004

Distribution pattern: Distribution US nationwide and Canada.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate quality system to include unvalidated manufacturing processes