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Exact Medical Manufacturing, Inc. recalls Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Recalled June 30, 2021 · FDA recall Z-1911-2021 · 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
12650 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
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Manufacturer(s)
Exact Medical Manufacturing, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →