Home / Recalls / Medical Devices
Exact Medical Manufacturing, Inc. recalls Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Recalled June 30, 2021 · FDA recall Z-1916-2021 · Exact Medical Manufacturing
Hazard
No 510k for the product to be used in a natural or surgical opening to the body · FDA Class II
Units
500 units
Sold at
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Description
No 510k for the product to be used in a natural or surgical opening to the body
Product
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
Manufacturer(s)
Exact Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →