Class 2 Device Recall FRAZIER OLIVE TIP Surgical Suction Instrument, 10 French

• Date Initiated by Firm: November 10, 2006
• Date Posted: March 13, 2007
• Recall Status: Terminated on July 31, 2012
• Recall Number: Z-0592-2007
• Recall Event ID: 37346
• Product Classification: Surgical Suction Instrument - Product Code GCJ
• Product: FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with Obturator in Place), REF 0033110. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
• Code Information: REF 0033110; All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
• Recalling Firm/ Manufacturer: Conmed Corporation; 525 French Road; Utica NY 13502-5945
• For Additional Information Contact: Dirk E. Stevens, PhD; 315-624-3361
• Manufacturer Reason for Recall: Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
• FDA Determined Cause: Packaging process control
• Action: 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.
• Quantity in Commerce: 15,549 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

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.