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U.S. Department of Health and Human Services

Class 2 Device Recall FRAZIER Olive Tip Suction Instrument, 10 French 50/C

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  Class 2 Device Recall FRAZIER Olive Tip Suction Instrument, 10 French 50/C see related information
Date Initiated by Firm September 12, 2007
Date Posted February 02, 2008
Recall Status1 Terminated 3 on August 30, 2012
Recall Number Z-0563-2008
Recall Event ID 45862
Product Classification Laparoscope - Product Code GCJ
Product FRAZIER Olive Tip Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 033110, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
Code Information Product Code: 0033110; All lot codes manufactured between 10/04/06 and 7/31/07 (lots 061004 through 070731). Lot codes on boxes and packaging contain a 6 digit lot code: For example, lot 061004: the first 2 digits represent the year manufactured (06 represents 2006), next 2 digits represent the month (10 represents October), the next 2 digits represent the day of the month (04).
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Road
Utica NY 13502-5945
For Additional Information Contact Ms. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall		 Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.
FDA Determined
Cause 2		 Packaging process control
Action URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.
Quantity in Commerce 6,969 instruments
Distribution Nationwide and Worldwide Distribution
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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