Recall Z-1641-2015— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1641-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-26

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2015-02-26, terminated 2015-11-17. It names one FDA 510(k) clearance: K141952. Product: ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.. Reason: During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Terminated: 2015-11-17
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCEDEthicon Endo-Surgery, Inc.·cleared 2014-11-24

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

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.

Reason for recall

During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

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