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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Lot Codes / Batch Numbers
Label Inserts: LB0013-1, LB0013-2, and LB0013-3.
Products Sold
Label Inserts: LB0013-1, LB0013-2, and LB0013-3.
Myelotec, Inc. is recalling Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. due to Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy deliver. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, OR
Page updated: Jan 10, 2026