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SafetyAlerts
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.

PRODUCT
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.

CODE
All lot numbers.

MANUFACTURER
Ethicon, Inc., Somerville, New Jersey.

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

DISTRIBUTION
Nationwide.

QUANTITY
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?

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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.