FDA Enforcement
Class II
Ongoing
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Recall: Z-0567-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0567-2026
- Event ID
- 97592
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ASP Global, LLC. dba Anatomy Supply Partners, LLC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 26, 2025
- Initiation Date
- September 26, 2025
- Classification Date
- November 19, 2025
- Address
- 7800 Third Flag Pkwy, Austell, GA, 30168-7657, United States
Description
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code Info
Model Number: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029
Distribution
Distribution US nationwide and Canada.
Quantity
27100