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Condoms Used in Safe-Sex Programs Are Recalled for Defects

The New York Times - Friday, December 1, 1995
Robert D. Mcfadden


Over the last month, the New York State Health Department has been recalling thousands of potentially defective condoms sent last summer to community-based organizations in the state for distribution to poor people, college students and other clients of safe-sex programs, health officials said yesterday.

While the recall involved 3 million Chinese-made Olympus brand condoms sent to the community organizations, and thousands were apparently given to and used by clients of the safe-sex programs, the officials characterized the dangers as minimal and the recall as a precaution undertaken by the state voluntarily.

Tests of samples found that 2 percent of the condoms leaked, but there have been no reports of anyone contracting AIDS as a result of using the condoms, the officials said. They said the condoms were not sold to the public, so the recall that began Nov. 1 was done quietly through the community groups and no announcement was made until inquiries were received from the news media yesterday.

"There's no danger to the general public," said Diane Mathis, a State Health Department spokeswoman. "A limited number of groups and people were involved. Our interest was in contacting them directly. A general announcement would have been a hit-and-miss way to reach these people."

Complaints about the condoms, which were imported from China and bought from a Las Vegas distributor by the state for $173,000, began soon after they were shipped last June to 250 community groups, about 150 of them in New York City, Ms. Mathis said.

The condoms -- all in boxes stamped with the lot number 950201 -- were sent by the Health Department's AIDS Institute to community groups to promote prevention of H.I.V., the virus that causes AIDS. They were given away, mostly to poor people but also to students at State University campuses and others taking safe-sex classes. No high school students received the condoms, Ms. Mathis said.

The defects were discovered during teaching demonstrations at the community organizations, Ms. Mathis said. The Federal Food and Drug Administration, which had tested the condoms before distribution and found no problems, was asked to conduct new tests, she said.

"A very small percentage of these condoms had problems," Ms. Mathis said. She said the F.D.A. found leaks in 7 of 353 condoms, or 2 percent, and insufficient levels of a spermicide, nonoxynol-9, in 10 of 37 other condoms, Ms. Mathis said.

The results of the F.D.A. tests were sent to Albany on Oct. 30. While the number of defects did not mandate a recall under F.D.A. rules, Dr. Barbara DeBuono, the State Health Commissioner, and the F.D.A. agreed that a voluntary recall was justified, Ms. Mathis said.

"The Health Department took immediate and appropriate steps to notify each of those organizations and provided them with instructions for notification of their clients who may have received the condoms," the Health Department said in a brief statement.

Alex Herman, a spokesman for Custom Services International, which imports, manufactures and distributes condoms, described the matter as "an isolated incident." He noted that the company, and not the state, was conducting the recall and said that it had collected thousands of boxed condoms that presumably had not been distributed by the community organizations.

Mr. Herman said it might be possible to deduce over the next few weeks how many of the suspect condoms had been given to people before the recall began. "We assume that a lot had been used," he said. "They began distributing them back in June."


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