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Exact Medical Manufacturing, Inc. recalls Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Recalled June 30, 2021 · FDA recall Z-1919-2021 · Exact Medical Manufacturing
Hazard
No 510k for the product to be used in a natural or surgical opening to the body · FDA Class II
Units
3000 units
Sold at
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Description
No 510k for the product to be used in a natural or surgical opening to the body
Product
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Manufacturer(s)
Exact Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →