Device product
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Z-0564-2026
Product summary
- Event
- Event 97592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 620502
- Official record key
device-enforcement:Z-0564-2026
Official wording
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Code information: Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189
Distribution pattern: Distribution US nationwide and Canada.
Derived failure modes
-
Manufacturing or process control
inadequate quality system to include unvalidated manufacturing processes