Recall Z-0149-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
| Date | Oct 16, 2019 (initiated Sep 19, 2019) |
| Status | Terminated |
| Reason | The sterile barrier of some devices may have been affected |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053433 | CAUTERY TIP CLEANER, MODEL 30500 Xodus Medical, Inc., Jan 19, 2006 |