Class 2 Device Recall AppleHunt Secondary Cannula/Pyramidal Tip Trocar

• Date Initiated by Firm: March 12, 2018
• Create Date: May 01, 2018
• Recall Status: Terminated on May 08, 2019
• Recall Number: Z-1584-2018
• Recall Event ID: 79825
• 510(K)Number: K911462
• Product Classification: Trocar - Product Code DRC
• Product: 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
• Code Information: Lot number 223333
• FEI Number: 1216677
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-9818
• Manufacturer Reason for Recall: Products have been packaged with the wrong Trocar length type.
• FDA Determined Cause: Under Investigation by firm
• Action: On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at recall@coopersurgical.com.
• Quantity in Commerce: 520 products
• Distribution: Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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