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Recall Observatory FDA recall evidence

Device product

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0001-2021

August 12, 2020

Class II

Product summary

Firm
Covidien, LP
Event
Event 86214
Status
Ongoing
Classification
Class II
Quantity
900,007 total
Official record key
device-enforcement:Z-0001-2021

Official wording

Reason: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information: Lot Numbers: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X

Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error