January 10, 2001FDA Issues Warning on
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,
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).
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.
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consumers of faulty products and contaminated foods. For complete information regarding
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