Device product
AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 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-0549-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49000
- Official record key
device-enforcement:Z-0549-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 07 7220 GTIN (Inner Pack): 30643351000094 UDI-DI: 10643351000090 All Lots produced from 01AUG2023 to 28FEB2025: 23H4114, 23I4054, 23J4036, 24A4107, 24H4123, 24I4324, 24L4007
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes