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U.S. Department of Health and Human Services

Class 2 Device Recall Genicon EZee Retrieval bag

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  Class 2 Device Recall Genicon EZee Retrieval bag see related information
Date Initiated by Firm June 27, 2018
Create Date May 14, 2020
Recall Status1 Open3, Classified
Recall Number Z-2005-2020
Recall Event ID 85403
510(K)Number K180579  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Code Information Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Recalling Firm/
Manufacturer		 Genicon, Inc.
6869 Stapoint Ct Ste 112
Winter Park FL 32792-6603
For Additional Information Contact Marianne Feyas
407-657-4851
Manufacturer Reason
for Recall		 Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
FDA Determined
Cause 2		 Labeling design
Action A recall notification letter and updated Instructions for Use (IFU) labeling was sent to consignees on 5/1/2020. The firm is asking that labeling be provided to surgeons for them to read and to familiarize themselves with proper use of the specimen bag for multiple retrievals in the same patient. An Acknowlegement/Receipt Form was provided with response required.
Quantity in Commerce 1550
Distribution Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = Genicon, Inc
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