FDA-Device2012-08-15Class II
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 products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
Afassco Inc
Hazard
The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."
Sold states
Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Affected count
1956 Boxes
Manufactured in
228 W Chestnut St, Orrville, OH, United States
Products
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 products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2012Don't want to check this manually?
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