Device 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 products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry
Z-2160-2012
Product summary
- Firm
- Afassco Inc
- Event
- Event 62645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1956 Boxes
- Official record key
device-enforcement:Z-2160-2012
Official wording
Reason: 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."
Code information: Recall involves finger cots model #s 5017 and 5018. There is no coding of the boxes or the cots
Distribution pattern: Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Derived failure modes
-
Unknown
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."