Device product

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

Z-0565-2026

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: 16920
Official record key: device-enforcement:Z-0565-2026

Official wording

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

Code information: Model Number: 07 9502 GTIN (Inner Pack): 30643351000353 UDI-DI: 10643351000359 All Lots produced from 01JUN2022 to 28FEB2025: 21G4272, 22F4084, 22F4109, 23A4170, 23H4154, 23H4228, 23I4057, 23I4058

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