Device product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Z-0562-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160250
- Official record key
device-enforcement:Z-0562-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0009 GTIN (Inner Pack): 30643351000315 UDI-DI: 10643351000311 All Lots produced from 31JUL2023 to 28FEB2025: 23H4156, 23I4015, 24B4198, 24F4187, 24I4313, 24J4133
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes