Z-0554-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- September 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1500
Product Description
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 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.
Distribution Pattern
Distribution US nationwide and Canada.
Code Information
Model Number: 07 7450 GTIN (Inner Pack): 30643351000193 UDI-DI: 10643351000199 All Lots produced from 01AUG2023 to 28FEB2025: 23H4158