Alerta De Seguridad para Oto-Ease® ear lubricant

Safety alert

2012-07-16

2012-07-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120716.html

Medical device safety alert: westone laboratories oto-ease® ear lubricant the united states food and drug administration (fda) has posted a safety alert concerning the recall of all sizes and packaging configurations of oto-ease® ear lubricant, manufactured by westone laboratories, inc.. from a consumer complaint, the fda found that the products are potentially contaminated with pathogenic bacteria and mold through sample analysis. the product is used for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids). microbial contaminations of the product could result in infectious complications of the ear canal and surrounding tissues. no injuries or illnesses have been reported to date. the fda suggested that consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm311978.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 16 july 2012.