Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Recall
- Recall Number
- Z-0149-2020
- Event Number
- 83819
- Firm
- Xodus Medical Inc
- FEI Number
- 1000221205
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- September 19, 2019
- Posted
- October 16, 2019
- Terminated
- March 4, 2024
- Address
- 702 Prominence Dr, New Kensington, PA, 15068-7052
Description
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
The sterile barrier of some devices may have been affected
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 [email protected] 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; [email protected] 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
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
464,040 eaches