Recall Z-0495-2022 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien Llc
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
| Date | Jan 13, 2022 (initiated Dec 6, 2021) |
| Status | Terminated |
| Reason | Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained. |
| Root cause | Device Design |
| Action | URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not |
| Quantity | 504 devices |
| Distribution | Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated Covidien, Nov 14, 2016 |