Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Expiration Date Labeling
Ecolab Inc is recalling Microtek Rolled Probe Cover PC0907NB because the inner carton box displays an incorrect expiration date.
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 is defined as unlikely to cause adverse health consequences. The issue is a documentation and labeling error regarding the expiration date on the inner carton, not a defect in the device itself.
Plain-English summary
Ecolab Inc is recalling 40 cases of Microtek Rolled Probe Cover PC0907NB, a prescription-only medical device. The product was distributed to the states of California, Florida, Michigan, New Jersey, Texas, Utah, and Virginia.
The recall was initiated because the inner carton box labels display an incorrect expiration date of 2015-10-01. The individual pouch labels and the outer shipper correctly display the expiration date of 2018-10-01. The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the product or return it to the distributor.
The recalled product
- Product
- Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
- Manufacturer
- Ecolab Inc
- Hazard
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 (1)
- 15302
Distribution
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