FDA recall Z-1912-2021

Exact Medical Manufacturing, Inc. · Class II · device

Product

6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N

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-1912-2021