FDA Enforcement
Class II
Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Recall: Z-0559-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0559-2026
- 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 Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code Info
Model Number: 06 0199 GTIN (Inner Pack): 30643351000322 UDI-DI: 10643351000328 All Lots produced from 31JUL2023 to 28FEB2025: 24B4199, 24E4128, 25B4098
Distribution
Distribution US nationwide and Canada.
Quantity
77500