Device product

Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

Z-0566-2026

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: 50250
Official record key: device-enforcement:Z-0566-2026

Official wording

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

Code information: Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131

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