Health Ministry recalls faulty condoms

The Kenya Pharmacy and Poisons Board has recalled two brands of male condoms after the products fell short in the quality assessment.

The defective products are manufactured by Cupid Limited and are branded Fiesta Stamina and Fiesta Big Black.

Samples tested from Fiesta Stamina (LOT Dl1608) were found to have hole after failing the Freedom from Holes test.

The Fiesta Big Black batch (LOT PL1625) failed the Thickness test.

The Ministry of Health wrote to pharmacists on November 20, 2018 ordering them to withdraw the two products from their shelves.

“You are hereby directed to immediately institute a recall of the affected batch. In addition, submit a recall plan within two days of the receipt of this letter,” read part of the letter.

Freedom from Holes test

This is a leakage test usually done on condoms both during the manufacturing process and by independent laboratories testing the finished product for quality assurance purposes.

Condoms are selected from batches and screened for tiny pinholes or weak spots that may allow passage of sperm or Sexually Transmitted Disease (STD) organisms.

A condom with a hole in it is clearly defective.

The batch of Fiesta Stamina that was sampled failed Freedom from Holes test.

Thickness Test

Condoms are also tested for areas that are visibly thin which can show up as bulges with well-defined edges during the freedom-from-holes test.

According to the World Health Organisation (WHO) the acceptable quality limit for condoms should be between 0.045mm and 0.080 mm in thickness. However, the normal thickness range for condoms is between 0.060mm and 0.080mm. Condoms thinner than 0.060mm are normally classified as thin, and those thicker than 0.080mm are typically classified as thick.

The thickness range chosen by WHO is to avoid both very thin and very thick condoms. Very thin products are likely to fail inflation requirements, while the very thick ones appear to offer no added effectiveness or may affect ‘pleasure’ and are likely to be less acceptable to users.

Products that fall off the recommended ranger are considered defective as they do not meet the set quality standard.

The Fiesta Big Black batch (LOT PL1625) failed the Thickness test.

Cupid LimitedFiesta StaminaFiesta Big BlackMinistry of Health