medical Class II Updated 2020-10-07

Covidien, LP recalls Endo GIA Auto Suture Gray Universal Articulating Loading Uni

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X
View official government recall

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