medical Class II Updated 2021-06-30

Exact Medical Manufacturing, Inc. recalls Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultraso

Recalled Product

Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA

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: 1908E209 1908E435 2005E171 2007E030
View official government recall

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