FlowGate2 neurovascular devices may exceed endotoxin limits due to inadequate testing
Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.
- Product
- FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
- Category
- Medical Device
- Distribution
- Distributed nationwide