Device product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
Z-0558-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 352750
- Official record key
device-enforcement:Z-0558-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0187 GTIN (Inner Pack): 30643351000285 UDI-DI: 10643351000281 All Lots produced from 31JUL2023 to 28FEB2025: 23I4063, 24A4108, 24B4197, 24D4023, 24E4137, 24E4278, 24L4004
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes