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U.S. Department of Health and Human Services

Class 3 Device Recall VCare, Standard/Small/Large Cervical Cup

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 Class 3 Recall
VCare, Standard/Small/Large Cervical Cup
see related information
Date Posted March 03, 2011
Recall Status1 Terminated on August 30, 2012
Recall Number Z-1520-2011
Recall Event ID 57841
Premarket Notification
510(K) Number
K071907 
Product Classification Cannula, Manipulator/Injector, Uterine - Product Code LKF
Product VCare® Vaginal-Cervical Ahluwalia's Retractor-Elevator devices. The VCare IFU is packaged one per carton of eight VCare Pouched Devices. The Instructions for Use is an 8.5" x 12" 12-page booklet and is packed loose in the carton. Only the carton will have to be opened to replace the old IFU; there is no need to open the sterile packaging of the individual VCare pouches. 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.
Code Information VCare¿ Standard Cervical Cup (Catalog # 60-6085-100), VCare¿ Small Cervical Cup (Catalog # 60-6085-101) and VCare¿ Large Cervical Cup (Catalog # 60-6085-102). Lot codes for product manufactured between 01/20/2009 (Lot 090120X) and through 07/31/2009 (Lot 090731X). Lot Code Key = YYMMDDX, where X = manufacturing shift (e.g. 1, 2 or 3)
Recalling Firm/
Manufacturer
ConMed Corporation
525 French Road
Utica, New York 13502
For Additional Information Contact M. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall
Product manufactured after 4/11/2008, but before 8/01/2009, contains the earlier Instructions For Use, IFU (PN 17416, Rev. D) which does not contain the revisions on the addition of Warning Notes 10 and 11 and the expansion of Warning Note 6 to the VCare¿ Instructions for Use. The reason for the field correction is to provide a copy of the revised IFU to all customers who may have unexpired Vcare¿
FDA Determined
Cause 2
DESIGN: Device Design
Action ConMed Corporation sent a communication to provide its direct consignees with important supplemental information concerning the Instructions for Use (IFU) for the VCARE® Vaginal-Cervical Ahluwalia's Retractor-Elevator uterine manipulators. The direct consignees were instructed to place a copy of the enclosed Instructions for Use, Part No. 14071 (Rev. A), with any inventory in your possession with an expiration date prior to August 2011 (2011-08) and replace any other Instructions for Use in thier possession. A copy of the enclosed Instructions for Use is already packaged with all devices bearing later expiration dates. Any inventory in their consignees possession with an expiration date prior to January 2011 (2011-01) is expired and should not be used. If the devices were further distributed to other facilities or distributors, or their consignees are a distributor, they were instructed to forward this information as appropriate to any known users of these devices. For questions regarding this recall call 315-624-3225. --- The IFU Warning changes are as follows: A new warning statement # 6 asks the user to verify the presence of all the components of the device upon removal of the VCARE® device from the patient. Although the prior IFU contained warnings about verifying that all components of the device were properly removed following use during surgery, the new statement expands the earlier, briefer statement. 6. Upon removing VCARE, the surgeon should visually inspect the VCARE device, and the patient, to make sure that the entire VCARE device was properly removed and that no components or fragments of these components were retained in the patient. There are 5 parts/components to the VCARE Cervical Elevator Retractor. These are: 1) the balloon; 2) the forward "cervical" cup; 3) the back or vaginal cup; 4) the locking assembly with thumb screw; 5) the metal shaft and handle with balloon inflation valve. --- A new warning statement # 10 further addresses.
Quantity in Commerce 31,028 VCare¿ Vaginal-Cervical Ahluwalia's Retractor-Elevator devices
Distribution Worldwide Distribution - USA including NY, TX, CA, IA, AZ, PA, IN, and KS and the countries of Austria, Jordan, Turkey, China, Portugal, Chile, Belgium, Ecuador, Brazil, Romania, Japan, Malaysia, India Switzerland, Colombia, Netherlands, Spain, Saudi Arabia, France, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LKF and Original Applicant = CONMED CORPORATION
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