The Recall Desk
LowFDA (Devices)·Z-2333-2018·Announced 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.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to incorrect documentation.

Plain-English summary

Ecolab Inc. is recalling 65 cases of Ecolab Microtek Rolled Probe Covers, Reference PC0906. The product is a sterile, prescription-only physical barrier used to protect diagnostic or surgical transducers from environmental exposure. The recall is being conducted because the products were shipped with incorrect instructions for use (IFU).

The affected lot numbers are D152291, D160961, D161161, D161311, D161371, and D161721. The products were distributed in the United States to the states of California, Illinois, Louisiana, South Carolina, Texas, and Wisconsin. There was no foreign, government, or military distribution.

The FDA has classified this as a Class III recall, which indicates that the violation is not likely to cause adverse health consequences. Users should stop using the affected products and contact Ecolab Inc. for further instructions.

The recalled product

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
Manufacturer
ECOLAB INC
Affected units
65

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot numbers D152291
  • D160961
  • D161161
  • D161311
  • D161371
  • and D161721.

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by ECOLAB INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →