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Class 2 Device Recall Myelotec Steerable Video Guided Catheter |
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Date Initiated by Firm |
December 19, 2007 |
Date Posted |
April 10, 2008 |
Recall Status1 |
Terminated 3 on December 03, 2008 |
Recall Number |
Z-0586-2008 |
Recall Event ID |
46317 |
510(K)Number |
K960194
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Product Classification |
arthroscope - Product Code HRX
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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. |
Code Information |
Label Inserts: LB0013-1, LB0013-2, and LB0013-3. |
Recalling Firm/ Manufacturer |
Myelotec, Inc. 4000 Northfield Way, Suite 900 Roswell GA 30076-4955
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For Additional Information Contact |
Ponzell C. Royster 770-664-4656 Ext. 133
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HRX and Original Applicant = MYELOTEC, INC.
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