—#50401

Product

FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: REF 0033180; 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).

Why it was recalled

Firm was made aware of instances where the sterile barrier of the instruments had been compromised.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2006-11-10
Posted by FDA: 2007-03-13
Terminated: 2012-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50401. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.