The Department of Health has asked for the statement below, on recalled condoms, to be distributed widely. It is critical to restore confidence in government's condom distribution programme and therefore the Treatment Action Campaign encourages the distribution of this statement. We welcome the Department's commitment to resolving this issue. We ask the Department and the South African Bureau of Standards to follow this up by indicating precisely what measures they have taken to reduce the likelihood of faulty condoms passing quality control again.
Please note that if you have condoms with the manufacturer's code 6809/MED/ on them, they should be returned to the Department of Health. The address is:
Department of Health - HIV Unit,
226 Vermeulen Street,
The following condoms should be returned:
* Those with the manufacturer's code 6809/MED/ (it is not clear what the brand name of these are but we [i.e. TAC] think it is Choice)
* Randy Rat
* Condom Concept
* African skins
* Choice – Lot number 4308/ZLX/
Media Statement by the Minister of Health on the Condom Distribution Programme
22 October 2007
Last month, the Department of Health stated that according to the internal audit at the South African Bureau of Standards (SABS) there were anomalies requiring a further investigation of more batches of condoms supplied by at least three of the seven companies responsible for the tender. These companies were Kohrs Medical, Juel Health and Sekunjalo.
The audit followed the charges that Zalatex (which distributed condoms produced by Latex Surgical Products) bribed an official of the SABS to approve condoms that were not conforming to the quality standards. The Department acted swiftly in removing from circulation condoms supplied by Zalatex that were suspected of not meeting the quality standard. More than 5 million condoms were recalled and another 7 million quarantined at the company’s warehouse.
The SABS recommended at the time that the Department quarantines the most recent batches of condoms supplied by these companies for retesting. This was intended to verify the quality of these condoms and inform the final conclusions of the audit process that was underway.
The SABS has reported to the Department that this verification process has been completed and the findings were as follows:
1.At least 5 batches belonging to Kohrs were sampled and they failed an airburst test. The SABS has reported to the Department of Health that based on the results, SABS was suspending Kohrs use of the SABS mark/certificate until remedial action is taken by the company to rectify the quality issues.
2.Samples tested relating to Juel Health and Sekunjalo were found to be of adequate quality.
Based on the conclusions of this audit process, the Department is recalling the products supplied by Kohrs. We appeal to the public and all partners involved in the distribution and promotion of the use of condoms to assist with the recall of these condoms. The condoms produced by Kohrs are identifiable with the manufacturer’s code 6809/MED/.
SABS has reported that, currently, there is no information suggesting collusion between Kohrs and the official of the SABS who is charged of corruption. However, the Department of Health notes that a large stock of condoms that was dumped at Inanda, in KwaZulu-Natal were produced by Kohrs. This matter is under police investigation.
During this financial year, Kohrs has supplied 5 million condoms to the Department. Of this, more than 1 million condoms have been quarantined at the distribution sites as part of the audit process. In the same way as we acted against Zalatex, the Department will no longer be procuring any stock from Kohrs.
The quantities that would have been supplied by Zalatex and Kohrs - which is 09 and 15 percent respectively of the projected 425 million male condoms supplied per annum - will be shared equitable amongst the other five companies over the remaining period of the contract ending in February 2008. SABS is satisfied with the quality of the condoms supplied by these five companies.
The SABS has indicated that extensive controls and verifications have been implemented throughout the testing and certification process to ensure that all condoms supplied under the SABS mark and under the Choice brand, comply with standards set by the World Health Organisation.
Condoms are a crucial element of the Department of Health’s programme to prevent sexually transmitted infections including HIV and unwanted pregnancies. The two incidents involving Zalatex and Kohrs should not be allowed to impact negatively on the significant progress we have made in promoting condom use in the country.
Through the Khomanani Campaign, the Department of Health will be making efforts to emphasise the messages that correct and consistent use of condoms is important in preventing sexually transmitted infections. We hope that other partners involved in the response to HIV, STIs and unwanted pregnancies can assist us in reinforcing the message that condoms are important in protecting our health.
Dr Manto Tshabalala-Msimang
Minister of Health