Recall Z-0178-2009 ยท LFK Catheter, Femoral
ConMed Corporation
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 Hysterectom
| Date | Oct 28, 2008 (initiated Sep 8, 2008) |
| Status | Terminated |
| Reason | 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 | Process change control |
| Action | 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. |
| Quantity | 32,453 (total devices) |
| Distribution | Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955446 | CONMED VCARE RETRACTOR/ELEVATOR Conmedcorp, Jun 18, 1996 |