Device product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Z-0561-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 947100
- Official record key
device-enforcement:Z-0561-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0007 GTIN (Inner Pack): 30643351000308 UDI-DI: 10643351000304 All Lots produced from 31JUL2023 to 28FEB2025: 23I4008, 24D4024, 24D4155, 24E4126, 24E4127, 24E4287
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes