medical Class II Updated 2021-06-30

Exact Medical Manufacturing, Inc. recalls 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands

Recalled Product

6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA

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: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071
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