Check supply shelves for recalled Ansell condoms
February 1, 1998
Check supply shelves for recalled Ansell condoms
Is your family planning clinic issuing spermicidally lubricated condoms made by Ansell Personal Products of Eatontown, NJ? Then you need to check the style names and expiration dates, because the company has issued a voluntary recall on some lots of eight of its styles.
The recall involves the following Ansell products with the specific expiration dates listed below. Expiration dates can be found on the individual condom wrapper, the package end-flap or back panel, and the master case:
• LifeStyles Ultra Sensitive with Spermicide, 10/97 (only);
• LifeStyles Assorted Colors with Spermicide, 10/97 through 6/98;
• LifeStyles Spermicidally Lubricated, 10/97 through 10/98;
• LifeStyles Vibra-Ribbed with Spermicide, 10/97 through 4/2000;
• LifeStyles Extra Strength with Spermicide, 10/97 through 4/2000;
• Prime Spermicidally Lubricated, 10/97 through 2/2000;
• Power Play with Spermicide, 10/97 through 2/2000;
• Intensity Assorted Colors with Spermicide, 11/97 (only).
Chances are, your clinic already has used the condoms in question, since 80% of them were manufactured three years ago. The company issued the public recall on Oct. 21 and notified all customers before the announcement, says Carol Carrozza, Ansell director of marketing. Since that time, less than half of 1% of the product that was initially shipped out has been returned, which leads the company to believe most of the affected condoms are no longer in circulation.
What prompted the recall?
The company decided to move forward after receiving just nine consumer complaints, all received over the summer of 1997, Carrozza says.
Ansell determined that some lots of the condoms may deteriorate before the end of their shelf life and may not adequately protect against pregnancy and sexually transmitted diseases. Using in-house testing, these lots were determined to no longer comply with standards required by the U.S. Food and Drug Adminis-tration (FDA). These standards include air inflation tests issued by the American Society for Testing Materials and adopted by the FDA two years ago.
Since no complaints had been received on the condoms in question before last summer, the company believes that most of the product in question met standards and performed effectively. But rather than risk any impaired product performance, Ansell decided to recall the lots in question representing 57 million condoms.
Few problems encountered
Condomania, a Los Angeles-based condom store with a large sales base on the Internet, has received only three questions about the recall, says Christopher Filkins, company Web master. That is an extremely low number, given that the World Wide Web site handles 2,000 potential customers a day, Filkins notes, adding that Condom-ania’s sales have not been affected in any way by the recall.
Although Ansell’s hotline buzzed nearly around the clock following the recall, the majority of the feedback concerning the manufacturer’s action has been positive, Carrozza says. The company has developed a "frequently asked questions" page on its World Wide Web site to address the most common queries from consumers and customers. (See resource box, at right.)
Many consumers are somewhat confused about the products involved in the recall, Carrozza says. This confusion may be due to headlines and broadcast highlights, which did not cover the specific expiration dates involved in the recall. Upon learning about the dates in question, many say they were unaware that condoms even carry such a designation.
"This is such a good opportunity to educate people and start talking about . . . expiration dates, lot traceability, and those kinds of things," she says. "It was just striking to me how many people did not know that condoms are a medical device."
Condoms, like any other manufactured product, can be expected to have defects from time to time, notes Michael Rosenberg, MD, MPH, clinical associate professor of OB/GYN and Epidemiology at the University of North Carolina at Chapel Hill and president of Health Decisions, a private research firm in Chapel Hill. The fact that this occurs infrequently should be reassuring to clinicians as well as users, he says.
"The fact that a manufacturing/quality control issue required a recall in one instance does not detract from the fact that properly used condoms can provide a highly reliable, inexpensive, readily available means of protecting against pregnancy and STDs," Rosenberg says.
At the same time, the occurrence of a recall can be disconcerting, he observes. He suggests that clinicians advise patients who are concerned to use the same caution they would with any other item potentially subject to recall.
For these concerned patients, clinicians may want to suggest they keep abreast of such recall announcements in the national media, Rosen-berg offers. As a precaution, suggest they purchase a condom supply to last several months. Stored properly, condoms will not lose efficacy over that period, and by planning ahead, news of any potential recall will filter out before they are used.
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