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U.S. Department of Health and Human Services

Class 2 Device Recall Valleylab Laparoscopic Handset

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  Class 2 Device Recall Valleylab Laparoscopic Handset see related information
Date Initiated by Firm January 26, 2017
Create Date April 18, 2017
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-1836-2017
Recall Event ID 76384
510(K)Number K964175  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB


Product Usage:
For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
Code Information E2750: 52990142X 52990142X 52990144X 52990144X 52990147X 52990147X 52990151X 52990151X 53250057X 53250057X 53250061X 53250061X 53250063X 53250063X 53250065X 53250065X 53610053X 53610053X 53610055X 53610055X 53610059X 53610059X 53610061X 53610061X 60240055X 60240055X 60240059X 60240059X 60240061X 60240061X 60240065X 60240065X 60520098X 60520098X 60520104X 60520104X 60870064X 60870064X 61220093X 61220093X 61220095X 61220095X 61220098X 61220098X 61300164X 61300164X 61540145X 61540145X 61540150X 61540150X E2750NSB: 52990145X 53250066X 61220096X 61540146X 
Recalling Firm/
Manufacturer		 COVIDIEN MEDTRONIC
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall		 Customer reports of the device handset continuing to operate after release of the activation button.
FDA Determined
Cause 2		 Device Design
Action A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Quantity in Commerce 24,703 Units
Distribution Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV
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 = VALLEYLAB, INC.
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