Z-2779-2017 Class II Ongoing

Recalled by Myelotec, Inc. — Roswell, GA

Recall Details

Product Type
Devices
Report Date
August 9, 2017
Initiation Date
March 2, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2980 units

Product Description

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

Reason for Recall

Obstructed/blocked port from defective VGC Access Port Body component.

Distribution Pattern

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

Code Information

Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214