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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Valley Lab

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  Class 2 Device Recall Covidien Valley Lab see related information
Date Initiated by Firm July 08, 2016
Create Date August 17, 2016
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-2572-2016
Recall Event ID 74602
510(K)Number K926481  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM
Item Code: E2782R28ASP
The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

Code Information Affected Lot Range: 213559X through 60520066X          
Recalling Firm/
Manufacturer
Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall
Potential for compromise of the package resulting in a breach of the sterile barrier
FDA Determined
Cause 2
Process control
Action Medtronic/Covidien sent an Urgent Medical Device Recall letter dated July 8, 2016, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. 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. Customers with questions were instructed to contact their Medtronic representative or Customer Service at 800-882-5878.
Quantity in Commerce 1440
Distribution Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
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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