FDAClass IIMay 27, 2015

ENDOPATH ECHELON" Vascular White Reload for Advanced recall

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally…

Why was ENDOPATH ECHELON" Vascular White Reload for Advanced recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..

Product
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally…
Recalling firm
Ethicon Endo-Surgery Inc
Quantity
6,744 devices
Distribution
Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
Recall date
May 27, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls