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
FDA Recall Z-2160-2012 · Posted 2012-08-08
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Recalling FirmAfassco Inc
Recall StatusTerminated
Product CodeFQM
Date Initiated2012-02-08
Date Terminated2014-01-14
Product Quantity1956 Boxes
Reason for Recall
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."
Firm Action
Afassco sent a Field Correction Notice to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Labels have been included with the notices that the firm will be sending to their distributors. The distributors were asked to examine their inventory and affix the caution label to the boxes of affected product. If additional warning labels are needed, they may contact Afassco (800-441-6774) for additional labels.
If they have further distributed these products, they should notify consignees of the field correction. Their notification to their customers may be enhanced by including a copy of the notice sent to them. The recall should be carried out to the user level. For any questions customers may call 1-880-441-6774.
For questions regarding this recall call 775-783-3555.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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