Device product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Z-0559-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 77500
- Official record key
device-enforcement:Z-0559-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0199 GTIN (Inner Pack): 30643351000322 UDI-DI: 10643351000328 All Lots produced from 31JUL2023 to 28FEB2025: 24B4199, 24E4128, 25B4098
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes