Afassco Multi-Colored Finger Cots Recalled for Missing Latex Warning Label
Afassco Inc. is voluntarily correcting a field issue for multi-colored finger cots that lack the required natural rubber latex warning label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary field correction for a missing warning label regarding a known allergen (latex). While latex allergies can be serious, the source text does not report any illnesses or injuries, and the agency classification is Class II, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Afassco Inc. is initiating a voluntary field correction for its multi-colored finger cots, models 5017 and 5018. The recall involves 1,956 boxes of the product, which are made of natural rubber and used to cover fingertip bandages when working with liquids. The product was distributed nationwide, including in California, Florida, Georgia, Hawaii, Illinois, Indiana, Michigan, New Hampshire, Nevada, Tennessee, Texas, and West Virginia.
The reason for the field correction is that the product was missing the required warning label stating: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions." The boxes and cots do not have specific coding, but the recall is limited to the specified model numbers.
Consumers who have these finger cots should stop using them and contact Afassco Inc. for further instructions. Individuals with known latex allergies should be particularly cautious and avoid using the product until the warning label is verified or the product is replaced.
The recalled product
- Product
- The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable…
- Manufacturer
- Afassco Inc
- Affected units
- 1,956
Distribution
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