Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe
FDA device recall Z-1957-2009 · posted 2009-07-02 · Terminated
Recall details
- Recalling firm
- Genico, Inc., dba Genicon
- 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.
- 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).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 470
- Distribution
- Worldwide Distribution -- US (MO and IA), United Kingdom, Netherlands and United Arab Republic.
- Date initiated
- 2008-05-08
- Date posted
- 2009-07-02
- Date terminated
- 2009-10-01
- Location
- Winter Park, FL
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