Recall Z-2779-2017— Myelotec, Inc.

Name: FDA recall Z-2779-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-02

Class II · Ongoing

Class II FDA medical device recall by Myelotec, Inc., initiated 2017-03-02. It names one FDA 510(k) clearance: K980734. Product: Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels. Reason: Obstructed/blocked port from defective VGC Access Port Body component..

Recalling firm: Myelotec, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-03-02
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K980734 — MYELOTEC VIDEO GUIDED CATHETERMyelotec, Inc.·cleared 1998-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.