France has ordered a recall of specified ultra-thin condoms made by Malaysia's Richter Rubber Technology Sdn. Bhd. after two lots failed safety tests, citing risks of infection and unintended pregnancy.
The French economy ministry said the 15 listed product references represent about 7 million condoms for the European Union market. Only some were sold in France, and the estimate is not a count of condoms recalled.
An order published Oct. 30 suspended importation and distribution of the listed products in France for one year. It also requires their withdrawal wherever they are found and their recall from users. The order assigns the cost of those measures to the parties responsible for placing the products on the French market.
The two lots failed checks for burst pressure, burst volume and perforations. The order says manually adding ammonia water to the latex bath could cause condoms made through that process to perform differently. Production records could not identify precisely which sublots might be affected, prompting action across a wider range of products.
The ministry said summer recalls of two products led to the investigation behind France's broader sales suspension. It said eight users had reported breakages involving lots found unsafe. The order also cites reports of unintended pregnancies but gives no number.
The French list includes products sold under several labels. Brand einhorn said its seven listed batches had passed manufacturer testing and, to its knowledge, had not been tested by French authorities. It said its products were not under recall in Germany.
A French consumer notice tells people holding ON) Super Thin lot 5995 to stop using it and contact the seller. The ministry recommends screening for sexually transmitted infections after use of a noncompliant condom and a pregnancy test if a period is late. The ministry said France's consumer watchdog would check that the withdrawal and recall are carried out.
