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Open, Classified

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

FDA Recall Z-2779-2017 · Posted None

Recalling FirmMyelotec, Inc.
Recall StatusOpen, Classified
Product CodeHRX
Date Initiated2017-03-02
Product Quantity2980 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980734MYELOTEC VIDEO GUIDED CATHETERMyelotec, Inc. · 1998-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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