FDA recall Z-1911-2021

Exact Medical Manufacturing, Inc. · Class II · device

Product

Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N

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-1911-2021