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Exact Medical Manufacturing, Inc. recalls Hays Ultrasound kit Item ID: H1000SE
Recalled June 30, 2021 · FDA recall Z-1918-2021 · 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
10020 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 Ultrasound kit Item ID: H1000SE
Manufacturer(s)
Exact Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →