FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Recall
- Recall Number
- Z-0584-2007
- Event Number
- 37346
- Firm
- Conmed Corporation
- FEI Number
- 3001451571
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- November 10, 2006
- Posted
- March 13, 2007
- Terminated
- July 31, 2012
- Address
- 525 French Road, Utica, NY, 13502-5945
Description
FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
On 11/10/06, ConMed Corp. sent "URGENT: DEVICE RECALL" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.
Worldwide
32,008 units