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U.S. Department of Health and Human Services

Class 2 Device Recall FRAZIER Surgical Suction Instrument, 8 French

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  Class 2 Device Recall FRAZIER Surgical Suction Instrument, 8 French see related information
Date Initiated by Firm November 10, 2006
Date Posted March 13, 2007
Recall Status1 Terminated 3 on July 31, 2012
Recall Number Z-0588-2007
Recall Event ID 37346
Product Classification Surgical Suction Instrument - Product Code GCJ
Product FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Code Information REF 0033080; 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 2		 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 711,245 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.
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