| Class 2 Device Recall 2010 Video Guided Catheter | |
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
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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
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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 |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HRX
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