Recall Z-2779-2017 ยท HRX Arthroscope
Myelotec, Inc.
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
| Date | Mar 2, 2017 |
| Status | Open, Classified |
| Reason | Obstructed/blocked port from defective VGC Access Port Body component. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980734 | MYELOTEC VIDEO GUIDED CATHETER Myelotec, Inc., Aug 11, 1998 |