Class 2 Device Recall Endo GIA Articulating Reloads with TriStaple Technology

• Date Initiated by Firm: May 17, 2019
• Create Date: June 16, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1830-2019
• Recall Event ID: 82950
• 510(K)Number: K111825 K160176
• Product Classification: Staple, implantable - Product Code GDW
• Product: EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Code Information: N8L0311KY N8M0063KY
• Recalling Firm/ Manufacturer: Covidien LLC; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Customer Service; 800-962-9888
• Manufacturer Reason for Recall: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
• FDA Determined Cause: Process control
• Action: All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
• Quantity in Commerce: 3,113,280
• Distribution: Nationwide domestic distribution, worldwide foreign distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GDW; 510(K)s with Product Code = GDW