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Recall Observatory FDA recall evidence

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

February 08, 2012

Class II

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

    reason.no_named_rule · v1.0.0

    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."