SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
FDA Recall #Z-0567-2026 — Class II — September 26, 2025
Product Description
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Reason for Recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Recalling Firm
ASP Global, LLC. dba Anatomy Supply Partners, LLC. — Austell, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
27100
Distribution
Distribution US nationwide and Canada.
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated