FDA Medical Device Recalls (openFDA)
Genico, Inc., dba Genicon: 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.
- Recall number
- Z-1957-2009
- Recalling firm
- Genico, Inc., dba Genicon
- 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.
- Status
- Terminated
- Initiated
- 2008-05-08
- Posted
- 2009-07-02
- Terminated
- 2009-10-01
- Reason
- 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.
- Root cause
- 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
- 470
- Distribution
- Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
- Lot, serial or model codes
- Lot Number 434071224.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 3002590791
- Firm city
- Winter Park
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28