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Recall Observatory FDA recall evidence

Device 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.

Z-1641-2015

February 26, 2015

Class II

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 71215
Status
Terminated
Classification
Class II
Quantity
6,744 devices
Official record key
device-enforcement:Z-1641-2015

Official wording

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.

Code information: 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..

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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