FDA Recall Terminated

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.

Recall: Z-1807-2020 · Initiated March 26, 2020

Recall

Recall Number: Z-1807-2020
Event Number: 85402
Firm: Stryker Instruments Div. of Stryker Corporation
FEI Number: 1811755
Product Code: GEI
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: March 26, 2020
Terminated: July 15, 2020
Address: 4100 E Milham Ave, Portage, MI, 49002-9704

Description

Reason

Due to a distribution error, product from the affected lot was shipped expired.

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 [email protected] 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 [email protected].

Distribution

International distribution the country of Canada.

Quantity

40 units