Device product

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

Z-2779-2017

March 02, 2017

Class II

Product summary

Firm: Myelotec, Inc.
Event: Event 77508
Status: Ongoing
Classification: Class II
Quantity: 2980 units
Official record key: device-enforcement:Z-2779-2017

Official wording

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

Code information: Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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