FDA recall Z-0009-2021

Product

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and Global Distribution.

Key facts

Status

Ongoing

Initiation date

2020-08-12

Report date

2020-10-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2021