FDA Enforcement
Class II
Ongoing
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Recall: Z-0565-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0565-2026
- 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 Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code Info
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
Distribution
Distribution US nationwide and Canada.
Quantity
16920