Recall Z-2151-2014 ยท EIE Dam, Rubber
Coltene Whaledent Inc
Latex Dental Dams labeled as Non-Latex Dental Dams
| Date | Aug 6, 2014 (initiated Dec 11, 2013) |
| Status | Terminated |
| Reason | Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. |
| Root cause | Packaging change control |
| Action | The firm issued a press release, called the distributor and sent a certified letter. The firm obtained the distributor's distribution list and sent recall notifications to all of these consignees.The firm included envelopes and return/reply cards, via response form mailed, certified mailing with return receipt. |
| Quantity | 32 boxes, 15 individual dams per box |
| Distribution | Distributed in Memphis, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.