Z-2779-2017Class II

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

Name: Z-2779-2017 Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Creator: Myelotec, Inc.
Published: 2017-03-02
License: https://open.fda.gov/license/

Myelotec, Inc. / initiated 2017-03-02 / Open, Classified / root cause: design

FDA source

Myelotec, Inc. began a recall of Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels on 2017-03-02. FDA classified it as Class II and gives the reason as "Obstructed/blocked port from defective VGC Access Port Body component". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2779-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-03-02
Posted: 2017-07-28
Recalling firm: Myelotec, Inc.
Product: Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Product code: HRX Arthroscope
Reason for recall: Obstructed/blocked port from defective VGC Access Port Body component.
Root cause tag: design
FDA root cause: Device Design
Action: Myelotec sent an Urgent Product Recall Notification letter dated April 10, 2017, to all affected customers. Customers are instructed to notify customers of any product further distributed, identify any recalled product on hand, and to complete the attached recall response, to be sent back to the distributor. For further questions, please call (770) 664-4656 Ext. 140.
Quantity in commerce: 2980 units
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
Product codes and lots: Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2779-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2779-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-08-09	2017-07-28

Product code HRX

K980734Class IIMyelotec Video Guided CatheterMyelotec, Inc. / cleared 1998-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)