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U.S. Department of Health and Human Services

Class 2 Device Recall 2010 Video Guided Catheter

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  Class 2 Device Recall 2010 Video Guided Catheter see related information
Date Initiated by Firm March 02, 2017
Create Date July 28, 2017
Recall Status1 Open3, Classified
Recall Number Z-2779-2017
Recall Event ID 77508
510(K)Number K980734  
Product Classification Arthroscope - Product Code HRX
Product Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Code Information Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214
Recalling Firm/
Manufacturer		 Myelotec, Inc.
4000 Northfield Way Ste 900
Roswell GA 30076-4955
For Additional Information Contact Richard Wunderlich
770-664-4656 Ext. 140
Manufacturer Reason
for Recall		 Obstructed/blocked port from defective VGC Access Port Body component.
FDA Determined
Cause 2		 Device Design
Action Myelotec sent an Urgent Product Recall Notification letter dated April 10, 2017, to all affected customers. Customers are instructed to notify customers of any product further distributed, identify any recalled product on hand, and to complete the attached recall response, to be sent back to the distributor. For further questions, please call (770) 664-4656 Ext. 140.
Quantity in Commerce 2980 units
Distribution Worldwide Distribution - US Distribution to the states of : CA, FL, KY, MN, and NJ ., and to the countries of : Brazil, Iran, Kuwait, Malaysia, Singapore, South Korea, Taiwan, and Turkey
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = MYELOTEC, INC.
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