Potential contamination of SINAQUA™ Dermal Gloves (Distributor Switzerland: gd medical AG, manufacturer: WELCARE INDUSTRIES S.p.A.)

12. August 2016

2 of 2 Lots of SINAQUA™ Dermal Gloves 2% chlorhexidine distributed in Switzerland were tested at the Basel University hospital. 24 samples were analyzed per lot, after vigorous validation experiments to ensure neutralization of Chlorhexidine and recovery of Burkholderia cepacia after artificial contamination.

All samples were negative for growth of gram-negative bacteria, in particular Burkholderia cepacia. Therefore, we did not find evidence of contamination of SINAQUA™ Dermal Gloves 2% chlorhexidine, and they can be used again.

However, some lots of SINAQUA™ Dermal Gloves without chlorhexidine are contaminated, and these products should not be used until further analyses have been completed. These products have been withdrawn from the  market by the Distributor link.

Best regards,

Andreas F. Widmer, MD, MS
for Swissnoso