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BD syringe packaging falls foul of Latin American altitude

This article was originally published in Clinica

Executive Summary

Becton Dickinson (BD) is recalling 64 lots of 60ml sterile disposable syringes in Brazil, after it emerged that a weakness in their individual "blister" packaging can cause the sterile seal to break at low atmospheric pressure, thus posing a risk of contamination. Tests conducted at their US manufacturing site have demonstrated that the seal can fail at pressures equivalent to altitudes of over 2,438 metres, according to a notice issued by BD-Brasil (Becton Dickinson Indústrias Cirúrgicas; São Paulo) and issued by regulatory agency Anvisa on August 21. At the time of going to press today, Clinica had been unable to ascertain whether other countries are affected.

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