Z-0567-2026 Class II Ongoing
FDA device recall Z-0567-2026 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: 27100.
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
- 27100
Product Description
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
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: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029