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

Recall date

March 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2779-2017

FDA classification

Class II

Brand / firm

Myelotec, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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