medical Class II Updated 2021-06-30

Exact Medical Manufacturing, Inc. recalls Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasoni

Recalled Product

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

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: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103
View official government recall

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