SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Mode...
FDA Recall #Z-0564-2026 — Class II — September 26, 2025
Product Description
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
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
620502
Distribution
Distribution US nationwide and Canada.
Code Information
Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated