FDA-Device2021-06-30Class II
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
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
36000
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1922-2021Don'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