ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
The incorrect IFU was shipped with the product.
US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2018