SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model...
FDA Recall #Z-0544-2026 — Class II — September 26, 2025
Product Description
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
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
78000
Distribution
Distribution US nationwide and Canada.
Code Information
Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated