FDA recall Z-0564-2026

ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Class II · device

Product

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.

Distribution

Distribution US nationwide and Canada.

Key facts

Status: Ongoing
Initiation date: 2025-09-26
Report date: 2025-11-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Austell, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2026