Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pedi...
FDA Recall #Z-1891-2024 — Class II — April 15, 2024
Product Description
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Reason for Recall
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Recalling Firm
Covidien, LP — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1681 units
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Code Information
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated