Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
This recall has been terminated (originally issued October 16, 2019).
- Company
- Xodus Medical Inc
- Recall Initiated
- September 19, 2019
- Posted
- October 16, 2019
- Terminated
- March 4, 2024
- Recall Number
- Z-0150-2020
- Quantity
- 460,000 eaches
- Firm Location
- New Kensington, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile barrier of some devices may have been affected
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
Lot / Code Info
Lot # 16DEC19 17JAN06 17FEB10 17MAR27 17OCT09 17OCT09A 17OCT23 17OCT23A 18JAN05 18JAN05A 18JAN19 18MAR02 18MAR19 18MAR19A UDI: Case 20787551000584 and Each - 00787551000580 Additional lots as of 6/8/20: 18APR09 18MAY01 18MAY11 18MAY25 18MAY25A 18MAY25B 18JUN27 18AUG14 18SEP12 18OCT03 Additional lots as of 9/9/2021: 18DEC05 18DEC26 18DEC26A 19JAN30 19JAN30A
Root Cause
Packaging
Action Taken
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