The Recall Desk

FDA (Devices) recall action 80160

ECOLAB INC recalled 2 products on 2018-07-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-07-11
Critical
0
Units
130

Why these products were recalled

The incorrect IFU was shipped with the product.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because they were shipped with incorrect instructions for use.

    Product
    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 flui
    Category
    Distribution
    6 states
  • LowFDA (Devices)··2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because the products were shipped with incorrect instructions for use.

    Product
    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 fluid
    Category
    Distribution
    6 states