medical Class II Updated 2021-06-30

Exact Medical Manufacturing, Inc. recalls Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic T

Recalled Product

Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N


Hazard / Issue

No 510k for the product to be used in a natural or surgical opening to the body

Issued by

FDA

Affected States: FL, MT, NY, OH, GA
Lot/Code Info: Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404
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