RecallDepth

Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

Company
Myelotec, Inc.
Recall Initiated
March 2, 2017
Recall Number
Z-2779-2017
Quantity
2980 units
Firm Location
Roswell, GA

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.

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