Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reported: October 7, 2020 Initiated: August 12, 2020 #Z-0003-2021
Product Description
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - 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.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 900,007 total
- Distribution
- Worldwide distribution - US Nationwide and Global Distribution.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.. Recalled by Covidien, LP. Units affected: 900,007 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-0003-2021.
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