Z-0566-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- September 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50250
Product Description
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Reason for Recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Distribution Pattern
Distribution US nationwide and Canada.
Code Information
Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131