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U.S. Department of Health and Human Services

Class 2 Device Recall Neptune Blade Electrode

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  Class 2 Device Recall Neptune Blade Electrode see related information
Date Initiated by Firm March 26, 2020
Create Date April 28, 2020
Recall Status1 Terminated 3 on July 15, 2020
Recall Number Z-1807-2020
Recall Event ID 85402
510(K)Number K182354  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information Lot 16240231, GTIN 07613327297799
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Erin Bissonnette
269-800-1348
Manufacturer Reason
for Recall		 Due to a distribution error, product from the affected lot was shipped expired.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 40 units
Distribution International distribution the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = LiNA Medical ApS
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