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U.S. Department of Health and Human Services

Class 2 Device Recall Genicon

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  Class 2 Device Recall Genicon see related information
Date Initiated by Firm May 08, 2008
Date Posted July 02, 2009
Recall Status1 Terminated 3 on October 01, 2009
Recall Number Z-1956-2009
Recall Event ID 50739
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM.

A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.

Code Information Lot Numbers: 441071225, 434071227, 434080237 and 434080373. 
Recalling Firm/
Genico, Inc., dba Genicon
6869 Stapoint Ct Ste 114
Winter Park FL 32792-6603
For Additional Information Contact
Manufacturer Reason
for Recall
Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.
FDA Determined
Cause 2
Nonconforming Material/Component
Action All four consignees were contacted by email and fax on May 8, 2008. Wholesalers were requested to forward copies of Genicon's recall letter dated May 8, 2009 and response form to their customers. Instructions for product return was provided. Direct questions about the recall to Genicon by calling 407-657-4851 (in United States) or 0118 930 5333 (in United Kingdom).
Quantity in Commerce 2,790
Distribution Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
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.