Recall Z-1807-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Instruments Div. of Stryker Corporation
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
| Date | Mar 26, 2020 |
| Status | Terminated |
| Reason | Due to a distribution error, product from the affected lot was shipped expired. |
| Root cause | Under Investigation by firm |
| Action | URGENT MEDICAL DEVICE RECALL notification letters dated 03/26/2020 were distributed to customers. Actions needed 1. Immediately check your internal inventory to locate the affected products. Quarantine and discontinue use of any recalled 165mm Blade Electrodes. 2. Return the enclosed Business Reply Form (BRF) by email to erin.bissonnette@stryker.com to confirm receipt of this notification and identify how many affected items are currently in your inventory. 3. Upon receipt of the completed BRF, Stryker will contact you to arrange for the return and replacement of your product(s). 4. Maintain |
| Quantity | 40 units |
| Distribution | International distribution the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182354 | SafeAir Telescopic Smoke Pencil Lina Medical Aps, Dec 14, 2018 |