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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- ECOLAB INC
- Hazard
- 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
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.
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