| Class 2 Device Recall Genicon | |
Date Initiated by Firm | May 08, 2008 |
Date Posted | July 02, 2009 |
Recall Status1 |
Terminated 3 on October 01, 2009 |
Recall Number | Z-1957-2009 |
Recall Event ID |
50739 |
Product Classification |
Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
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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 700-010-005, 10MM (Foreign Distribution Only).
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 Number 434071224. |
Recalling Firm/ Manufacturer |
Genico, Inc., dba Genicon 6869 Stapoint Ct Ste 114 Winter Park FL 32792-6603
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For Additional Information Contact | 407-657-4851 |
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 | 470 |
Distribution | Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic. |
Total Product Life Cycle | TPLC Device Report |
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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.
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