Device Recall VCare, Standard/Small/Large Cervical Cup 의 리콜

Recall

57841

Class 3

Z-1520-2011

2011-02-02

2011-03-03

Terminated

United States

2012-08-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97537

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¿.

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