Z-0553-2026 Class II Ongoing
FDA device recall Z-0553-2026 was initiated by ASP Global, LLC. dba Anatomy Supply Partners, LLC. on September 26, 2025 and is designated Class II. Reason for recall: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. The recall status is ongoing. Affected quantity: 2100.
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
- 2100
Product Description
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 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 7340 GTIN (Inner Pack): 30643351000131 UDI-DI: 10643351000137 All Lots produced from 01AUG2023 to 28FEB2025: 24B4201, 24K4372