Device product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Z-0547-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27950
- Official record key
device-enforcement:Z-0547-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 07 7150 GTIN (Inner Pack): 30643351000162 UDI-DI: 10643351000168 All Lots produced from 01AUG2023 to 28FEB2025: 23I4024, 24B4196, 24H4129, 24J4135, 24J4345, 25B4104
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes