Class 2 Device Recall ReNew brand Disposable Scissor and Dissector Tips

• Date Initiated by Firm: November 01, 2017
• Create Date: May 08, 2018
• Recall Status: Terminated on September 17, 2019
• Recall Number: Z-1740-2018
• Recall Event ID: 79435
• 510(K)Number: K981389
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
• Code Information: Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989
• Recalling Firm/ Manufacturer: Microline Surgical, Inc.; 50 Dunham Rd; Suite 1500; Beverly MA 01915-1882
• For Additional Information Contact: Scott Marchand Davis; 978-867-1758
• Manufacturer Reason for Recall: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
• FDA Determined Cause: Process control
• Action: Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to suggest that the sterile barrier provided by the sealed pouches were damaged because of the rework, but are initiating this recall out of an abundance of caution because if a sterile barrier was compromised, there is potential that use of the device could result in an infection. If you experience any adverse events or quality problems with the use of this product, you should report this to FDAs MedWatch Adverse Event Reporting Program and to Microline as soon as possible. All product returned will be replaced at no cost. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or inf o@m icr olinesur g ical.com. with any further questions. For further questions, please call (978) 867-1758.
• Quantity in Commerce: 12 box of 10 tips each
• Distribution: Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
• 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 = GEI