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U.S. Department of Health and Human Services

Class 2 Device Recall Myelotec Steerable Video Guided Catheter

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  Class 2 Device Recall Myelotec Steerable Video Guided Catheter see related information
Date Initiated by Firm December 19, 2007
Date Posted April 10, 2008
Recall Status1 Terminated 3 on December 03, 2008
Recall Number Z-0587-2008
Recall Event ID 46317
510(K)Number K980734  
Product Classification arthroscope - Product Code HRX
Product Myelotec¿ Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.
Code Information Label Insert: LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4.
Recalling Firm/
Manufacturer		 Myelotec, Inc.
4000 Northfield Way, Suite 900
Roswell GA 30076-4955
For Additional Information Contact Ponzell C. Royster
770-664-4656 Ext. 133
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = MYELOTEC, INC.
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