Recall Z-1025-2013 ยท FZZ Marker, Skin
Viscot Medical LLC
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
| Date | Mar 29, 2013 (initiated Aug 22, 2012) |
| Status | Terminated |
| Reason | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. |
| Root cause | Device Design |
| Action | Viscot Medical LLC sent a Customer Notification Letter dated August 22, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product for a replacement. To return the product call 1-800-221-0658 or e-mail jeffl@viscot .com for the RGA. |
| Quantity | 458,589 markers |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.