Z-0009-2021 Class II Ongoing
FDA device recall Z-0009-2021 was initiated by Covidien, LP on August 12, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 900,007 total.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 12, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900,007 total
Product Description
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 Pattern
Worldwide distribution - US Nationwide and Global Distribution.
Code Information
Lot Numbers: 00Z2117