ECOLAB INC recalls ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/…

Recall date

November 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2333-2018

FDA classification

Class III

Brand / firm

ECOLAB INC

Sold / distributed

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

Why it was recalled

The incorrect IFU was shipped with the product.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, 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).