Recall Z-2160-2012 ยท FQM Bandage, Elastic
Afassco Inc
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
| Date | Aug 8, 2012 (initiated Feb 8, 2012) |
| Status | Terminated |
| 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." |
| Root cause | Packaging process control |
| 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 notifica |
| Quantity | 1956 Boxes |
| Distribution | Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.