Z-1891-2024 Class II Ongoing

Recalled by Covidien, LP — North Haven, CT

Recall Details

Product Type
Devices
Report Date
June 5, 2024
Initiation Date
April 15, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1681 units

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

Distribution Pattern

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