Z-0544-2026 Class II Ongoing
FDA device recall Z-0544-2026 was initiated by ASP Global, LLC. Dba Anatomy Supply Partners, LLC. on Sep 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: 78000.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 26, 2025
- Initiation Date
- Sep 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78000
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.
Distribution Pattern
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