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.
This recall has been terminated (originally issued July 2, 2009).
- Company
- Genico, Inc., Dba Genicon
- Recall Initiated
- May 8, 2008
- Posted
- July 2, 2009
- Terminated
- October 1, 2009
- Recall Number
- Z-1957-2009
- Quantity
- 470
- Firm Location
- Winter Park, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
Lot / Code Info
Lot Number 434071224.
Root Cause
Nonconforming Material/Component
Action Taken
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).