—#73266

Product

VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-100. Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502. The ConMed VCARE Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

FDA product code: LFK — Catheter, Femoral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K955446
Affected lot / code info: Lots 0710121x through and including 0804111x [yymmddx where x = shift code 1,2, or 3] . All lots of the recalled devices were manufactured between and including October 12, 2007 and April 11, 2008.

Why it was recalled

The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.

Root cause (FDA determination)

Process change control

Action the firm took

The domestic recall notices were mailed on 9/08/08 by USP Priority Mail pouches. The international notices were sent via FedEx International Priority on 9/08/08. The letter described the problem, the health risk and requested that customers inventory the product and return them back to the firm. Customers are requested to fax the reply form to the firm. Contact ConMed Corporation at 1-800-765-8375, ext 3237 for assistance.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

Distribution pattern: Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland

Timeline

Recall initiated: 2008-09-08
Posted by FDA: 2008-10-28
Terminated: 2012-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73266. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.