Recall Z-0586-2008 ยท HRX Arthroscope
Myelotec, Inc.
Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
| Date | Apr 10, 2008 (initiated Dec 19, 2007) |
| Status | Terminated |
| Reason | Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation. |
| Root cause | Error in labeling |
| Action | Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec. |
| Quantity | 1,252 shipping containers |
| Distribution | Worldwide Distribution --- USA including states of AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, and OR, and countries of Aurba, Korea, Japan, Switzerland, South Africa, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960194 | MYELOTEC MYELOSCOPE Myelotec, Inc., Sep 4, 1996 |