Disposable Glove Recall
Warning: The disposable washing gloves "Sinaqua Dermal Glove" may be contaminated with bacteria. The distribution company is therefore recalling the affected batches.
Within the framework of market surveillance for medical devices, Swissmedic was notified of contamination of disposable washing gloves with the bacterial species Burkholderia cepacia. These bacteria can cause severe infections. The Swiss distributor has recalled the affected batches from the market.
The reasons for the contamination are not yet known. The Italian manufacturer is currently investigating the matter. The gloves are used, among other things, for local skin cleansing before and after operations or for body care of sensitive skin areas.
The Swiss distribution company has decided to withdraw all potentially affected batches delivered in Switzerland between November 2015 and May 2016 and not to deliver goods again until they are free of defects.
All supplied customers were contacted directly by the distribution company. Swissmedic published the recall on its website and informed all contact persons in the hospitals accordingly.
Users are asked to stop using the disposable washing gloves "SINAQUA Dermal Glove", article no. WEL-95580, at the moment.
In this context, Swissmedic reminds hospitals of their responsibility to maintain an internal reporting system and to report serious incidents involving medical devices to the Institute.
