Class 2 Device Recall Electrosurgical Tip Cleaner

• Date Initiated by Firm: September 19, 2019
• Date Posted: October 16, 2019
• Recall Status: Terminated on March 04, 2024
• Recall Number: Z-0149-2020
• Recall Event ID: 83819
• 510(K)Number: K053433
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Electrosurgical Tip Cleaner; REF: 138029; ; Product Usage: electrosurgical accessory
• Code Information: Lot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29
• Recalling Firm/ Manufacturer: Xodus Medical Inc; 702 Prominence Dr; New Kensington PA 15068-7052
• For Additional Information Contact: Paul Lloyd; 724-337-5500
• Manufacturer Reason for Recall: The sterile barrier of some devices may have been affected
• FDA Determined Cause: Packaging
• Action: Urgent Medical Device Voluntary Recall notification letters dated 9/20/19 were sent to customers. An Urgent Medical Device Voluntary Recall REVISED RECALL NOTICE notification letters were sent to customers on 9/27/19. 1. Immediately check your inventory and quarantine affected stock on hand. 2. The following process shall be undertaken in order to segregate any affected inventory. The existing inventory shall be inspected and any affected product quarantined and destroyed. A. Inspect the Tyvek pouch seal integrity. B. Secondly, the product contained within the pouch may be partially sealed into the Tyvek seal itself. 3. unaffected product shall be distributed with no futher action necessary. 4. For any product that is quarantined and must be destroyed: A. Xodus Medical requires documentation of the affected inventory that is found to be affected and destroyed. Information regarding the following shall be documented and provided to Xodus Medical. B. Product Number; Quantity Affected; Method of Destruction; Evidence of Destruction. It can be photos or videos of product being destroyed 5. Please immediately complete the attached Acknowledgement form even if you do not have any affected stock, and return the acknowledgement to Xodus Medical at the following: Email PLloyd@XodusMedical.com or Fax +1 724-337-1131 For further information and question, please call Paul Lloyd, Vice President, Global QA/RA & Technology, Xodus Medical; +1 724-337-5500; PLloyd@XodusMedical.com Urgent: Medical Device Voluntary Recall REVISED RECALL NOTICE dated 6/8/20 were sent to customers. Xodus Medical has received complaints of some devices where the sterile barrier of some devices may have been affected. Xodus Medical has confirmed instances where the pouch seal was compromised on some of the reported product. In no instance has it been reported to Xodus Medical that a compromise in the sterile barrier has resul
• Quantity in Commerce: 464,040 eaches
• Distribution: Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico
• 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 and Original Applicant = XODUS MEDICAL, INC.