FDA-Device2021-06-30Class II
Hays Ultrasound kit Item ID: H1000SE
Exact Medical Manufacturing, Inc.
Hazard
No 510k for the product to be used in a natural or surgical opening to the body
Sold states
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Affected count
10020 units
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
Hays Ultrasound kit Item ID: H1000SE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief