—#66292

Product

FRAZIER Surgical Suction Instrument, 3 French with Control and Obturator, Product Code: 0031030, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product Code: 0031030; 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).

Why it was recalled

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Conmed Corporation
Address: 525 French Road, Utica, New York 13502-5945

Distribution

Distribution pattern: Nationwide and Worldwide Distribution

Timeline

Recall initiated: 2007-09-12
Posted by FDA: 2008-02-02
Terminated: 2012-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66292. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.