FDA recall Z-1918-2021
Exact Medical Manufacturing, Inc. · Class II · device
Product
Hays Ultrasound kit Item ID: H1000SE
Reason for recall
No 510k for the product to be used in a natural or surgical opening to the body
Distribution
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2021-04-29
- Report date
- 2021-06-30
- Termination date
- 2022-05-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lancaster, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2021