Blood gas cartridges recalled for lacking clearance covering updated measurement ranges
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
- Product
- i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Category
- Medical Device
- Distribution
- Distributed nationwide