—#180749

Product

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K182354
Affected lot / code info: Lot 16240231, GTIN 07613327297799

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: International distribution the country of Canada.

Timeline

Recall initiated: 2020-03-26
Terminated: 2020-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.