Ethicon, Inc

Product code 2179  Lot 520198, exp June 2010; Lot 520200, exp June 2010.

General and Plastic Surgery Devices

1

No

The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.

J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.

Product Code: 00480; Lot #s:  0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.

Obstetrical and Gynecological Devices

2

No

Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.

VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.