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.
This recall has been terminated (originally issued March 26, 2020).
- Recall Initiated
- March 26, 2020
- Terminated
- July 15, 2020
- Recall Number
- Z-1807-2020
- Quantity
- 40 units
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Due to a distribution error, product from the affected lot was shipped expired.
Distribution
International distribution the country of Canada.
Lot / Code Info
Lot 16240231, GTIN 07613327297799
Root Cause
Under Investigation by firm
Action Taken
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 awareness of this communication internally until all required actions have been completed within your facility. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate. Please complete and sign this form. Email the completed form to erin.bissonnette@stryker.com.