Ultrasonic Probe Covers Lack FDA Clearance for Body Use
Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.
- Product
- Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
- Category
- Medical Device
- Distribution
- 6 states