medical Class II Updated 2020-10-07

Covidien, LP recalls Endo GIA Auto Suture Universal Articulating Loading Unit 30

Recalled Product

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - 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: T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X
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