FDA recall Z-2779-2017

Product

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

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

Key facts

Status

Ongoing

Initiation date

2017-03-02

Report date

2017-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Roswell, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2779-2017