CardioQuip Cooler-Heater Device Lacks Water-Quality and Inspection Guidance
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
- Product
- CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
- Category
- Medical Device
- Distribution
- Distributed nationwide