Device product

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Z-0555-2026

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: 2000
Official record key: device-enforcement:Z-0555-2026

Official wording

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

Code information: Model Number: 06 0507 GTIN (Inner Pack): 30643351000391 UDI-DI: 10643351000397 All Lots produced from 31JUL2023 to 28FEB2025: 24B4200

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