Alerta De Seguridad para durex polyisoprene synthetic latex condoms

Safety alert

2018-07-20

2018-07-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180730.html

Medical device safety alert: durex polyisoprene (pi) synthetic latex condoms medical device manufacturer, reckitt benckiser, has issued a medical device safety alert concerning its durex polyisoprene (pi) synthetic latex condoms. the manufacturer recently found that a small number of pi synthetic latex condoms made earlier this year are not passing its stringent quality tests. according to the manufacturer, the tests have shown that while all pi synthetic latex condoms which are currently on the market in all countries are expected to be above the international quality standard (iso 23409:2011) for male condoms of this type, recently a small number of condom batches did not pass retesting against the more stringent quality standard. there have been no adverse events reported in relation to any of these batches of condoms and there is no immediate safety concern for consumers, and the issue does not present a significant or unacceptable risk. product recall is on-going. according to the local supplier, the events do not impact any pi synthetic latex condoms, namely durex real feel condoms, that are marketed in hong kong. all batches of durex pi synthetic latex condoms sold in hong kong have been retested and stress tested and continue to meet the stringent quality requirements for quality. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 july 2018.