Device product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 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-0545-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50050
- Official record key
device-enforcement:Z-0545-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 07 7120 GTIN (Inner Pack): 30643351000087 UDI-DI: 10643351000144 All Lots produced from 01AUG2023 to 28FEB2025: 24H4127, 24I4326, 24J4134, 24J4344, 24K4370, 24L4005, 25B4103
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes