Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
Hazard
Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
What You Should Do
Remedy
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.
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Products
Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
- Brand
- Myelotec, Inc.
- UPC
- Label Inserts: LB0013-1, LB0013-2, and LB0013-3.
Units Affected
1,252 shipping containers