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FDAFDA · Food and drugs·Recall number Z-2779-2017

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

Published August 9, 2017 · Recall initiated: March 2, 2017

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Myelotec, Inc.
Distributor
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
Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214
Risk classification
Class II
Area (FDA)
device
Country
United States

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