FDA Enforcement
Class II
Ongoing
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Recall: Z-0566-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0566-2026
- 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
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code Info
Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131
Distribution
Distribution US nationwide and Canada.
Quantity
50250