Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
- Company
- Myelotec, Inc.
- Recall Initiated
- December 19, 2007
- Posted
- April 10, 2008
- Terminated
- December 3, 2008
- Recall Number
- Z-0586-2008
- Quantity
- 1,252 shipping containers
- Firm Location
- Roswell, GA
Reason for Recall
Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
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.
Lot / Code Info
Label Inserts: LB0013-1, LB0013-2, and LB0013-3.
Root Cause
Error in labeling
Action Taken
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.