FDA-Device2020-10-07Class IIPROCESSING DEFECT
Covidien Endo GIA Auto Suture stapler recalled for incomplete staple formation
OTHERNationwide distribution
Stop using affected Covidien Endo GIA staplers
Certain Covidien Endo GIA Auto Suture staplers may fail to form staples properly during surgery, which could prevent adequate wound closure and bleeding control. This assembly defect affects specific lot numbers used in abdominal, gynecologic, pediatric, and thoracic surgical procedures.
- Check your inventory for affected lot numbers: T0A108X, T7H003X, T8D008X, T8K108X, T9G060X, T0E051X, T7L023X, T8H047X, T8M079X, T7G003X, T8D007X, T8K047X, T9F132X
- Stop using any stapler matching these lot numbers immediately
- Contact Covidien or your hospital supply chain for replacement instructions
- Review any recent surgeries using affected devices with your surgical team
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and Global Distribution.
Affected count
900,007 total
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2021Don't want to check this manually?
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