Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
FDA Recall Z-0586-2008 · Posted 2008-04-10
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Recalling FirmMyelotec, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2007-12-19
Date Terminated2008-12-03
Product Quantity1,252 shipping containers
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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