Z-0565-2026 Class II Ongoing
FDA device recall Z-0565-2026 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: 16920.
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
- 16920
Product Description
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
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 9502 GTIN (Inner Pack): 30643351000353 UDI-DI: 10643351000359 All Lots produced from 01JUN2022 to 28FEB2025: 21G4272, 22F4084, 22F4109, 23A4170, 23H4154, 23H4228, 23I4057, 23I4058