Device product

SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

Z-0567-2026

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: 27100
Official record key: device-enforcement:Z-0567-2026

Official wording

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

Code information: Model Number: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029

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