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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 Cathetersee related information
Date Initiated by FirmMarch 02, 2017
Create DateJuly 28, 2017
Recall Status1 Open3, Classified
Recall NumberZ-2779-2017
Recall Event ID 77508
510(K)NumberK980734 
Product Classification Arthroscope - Product Code HRX
ProductMyelotec 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 ContactRichard 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
ActionMyelotec 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 Commerce2980 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = HRX
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