Safety Alerts Saves Lives
Safety Alerts  
Home Privacy About Us Contact Us Change Preferences

January 10, 2001

FDA Issues Warning on Gynecological Device

Somerville, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) issued a safety alert today stating that Ethicon, Inc. is recalling its Gynecare Versapoint Bipolar Electrosurgery Electrodes and Connector Cables because the device may cause gas embolism events during hysteroscopic surgery.

Gynecare Versapoint Bipolar Electrosurgery Electrodes
and Connector Cables:
a) Resectoscope Electrode (Product Codes 1930, 1939, 1948, 1950, 1980, 1985);
b) Electrode--Spriong Tip, 5 FR (Product Codes 0471, 0472);
c) Electrode--Twizzle Tip, 5 FR (Product Codes 0470, 0467);
d) Electrode--Ball Tip, 5 FR (Product Codes 0466, 0469).
e) RN-001/004-1.

All lot numbers.

Ethicon, Inc., Somerville, New Jersey.

Manufacturer, by letter, dated September 22, 2000. Voluntary safety alert.


2400 electrodes and 400 hand pieces were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

SafetyAlerts compiles comprehensive safety recall information for the United States. SafetyAlerts Newsletter is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit:



The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.