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.
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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific issue is a documentation error (incorrect IFU) rather than a physical defect or contamination.
Plain-English summary
Ecolab Inc. is recalling 65 cases of Ecolab Microtek Rolled Probe Covers, Reference PC0905. The product is a sterile, prescription-only physical barrier used to protect ultrasound or surgical transducers from environmental exposure and maintain hygienic levels during diagnostic or surgical procedures.
The recall was initiated because the product was shipped with incorrect instructions for use (IFU). The affected lot numbers are D151871, D151961, D161861, D162001, and D162911. The product was 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 U.S. Food and Drug Administration classifies this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare facilities should stop using the affected probe covers and contact Ecolab Inc. for further instructions or a replacement.
The recalled product
- 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…
- 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 (5)
- Lot numbers D151871
- D151961
- D161861
- D162001
- and D162911
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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