Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
This recall is currently active, issued March 2, 2017. It was issued by Myelotec, Inc..
- Company
- Myelotec, Inc.
- Recall Initiated
- March 2, 2017
- Recall Number
- Z-2779-2017
- Quantity
- 2980 units
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Obstructed/blocked port from defective VGC Access Port Body component.
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
Lot / Code Info
Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214
Root Cause
Device Design
Action Taken
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.