"SINAQUA™ Dermal Glove" disposable washing gloves recalled due to the risk of bacterial infections

Bern, 08.07.2016 - As part of market surveillance activities for medical devices, a case of contamination of disposable washing gloves with the bacterial species Burkholderia cepacia has been reported to Swissmedic. These bacteria can cause severe infections. The Swiss distributor has recalled the affected batches.

The reasons for the contamination are not yet known. Appropriate investigations are underway at the Italian manufacturer. The gloves are used partly for topical skin cleansing before and after operations or for personal hygiene on sensitive skin areas.

The Swiss distributor has decided to withdraw all potentially affected batches that were delivered to Switzerland between November 2015 and May 2016, and to resume delivery of the product only when it is flawless.

The distributor has written directly to all the customers it has supplied. Swissmedic has published the recall on its website and informed all hospital contact people.

Users are asked to stop using the "SINAQUA™ Dermal Glove" disposable washing gloves, article description WEL-95580.

In this connection, Swissmedic would remind hospitals of their responsibility to maintain an internal reporting system and their obligation to inform the Agency of any serious incidents involving medical devices.

Address for enquiries

Lukas Jaggi, Acting spokesman (ad interim)
+41 58 462 02 76
media@swissmedic.ch