Device product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Z-0557-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 397000
- Official record key
device-enforcement:Z-0557-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0186 GTIN (Inner Pack): 30643351000278 UDI-DI: 10643351000274 ***All Lots produced from 31JUL2023 to 28FEB2025: 23H4108, 23H4155, 23I4014, 23I4062, 23J4040, 24F4188, 24I4314, 24L4002, 25B4097
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes