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Recall Observatory FDA recall evidence

Device product

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Z-0557-2026

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
397000
Official record key
device-enforcement:Z-0557-2026

Official wording

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

Code information: Model Number: 06 0186 GTIN (Inner Pack): 30643351000278 UDI-DI: 10643351000274 ***All Lots produced from 31JUL2023 to 28FEB2025: 23H4108, 23H4155, 23I4014, 23I4062, 23J4040, 24F4188, 24I4314, 24L4002, 25B4097

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