The Spanish Agency for medicines and health products (AEMPS) that ensures the safety of these products has distributed a note in which it warns that it is necessary destroy the Wawau Baby march medicine pacifier.
The note explains that it is expressly distributed so that parents and caregivers who may still have the “Pacifier for medicines” product, reference FS012, in various colors, manufactured by RSW International Ltd. (United Kingdom) 'and distributed by Wawau Baby, don't use it and destroy it.
This product is used to administer medications to babies and children but does not comply with the regulation of medical devices and does not carry the CE marking and instructions for use in Spanish.
The British Agency for safety in medicines and health products alerted the manufacturer in June 2009 as there is a possibility of dose confusion and a case of overdose in a six-month-old baby had been found.
The distribution company in Spain alerted the selling establishments to withdraw them but of the 1227 units that had been distributed only 47 have been recovered, which suggests that many units may be held by consumers.
The recommendation of the Spanish Agency for medicines and health products is clear, if anyone has a Wawau Baby medicine pacifier with the indicated reference should not use it and should destroy it.
