Medical Devices

Medical device safety information

The manufacturer or authorised representative of the manufacturer of a medical device must notify the Agency for Medicinal Products and Medical Devices in writing of any corrective action it intends to carry out in order to reduce as far as possible the possibility of a recurrence of an adverse incident concerning the medical device.

In addition to notifying the Agency, the manufacturer or authorised representative of the manufacturer of a medical device must notify users about the corrective action by providing safety information using a method that guarantees that all users are notified. The safety information should be in Croatian language and include the elements set out in Annex III of the Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13).

We present received safety information notifications below.

DIALAB - DOA SALIVA MULTI-6 TEST

09.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer DIALAB GmbH, Austria on the recall of several lots of the product DOA SALIVA MULTI-6 TEST due to possibilities of false negative results for THC.

The manufacturer has informed users that the affected lots of DOA SALIVA MULTI-6 TEST may yield false negative results to THC, whereas for other investigated substances the test provides reliable results.

Detailed information is accessible under the following link.

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Biometrix 8.5 Fr 4 Lumen CVC Set

08.01.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Biometrix Ltd, Israel on the recall of the medical device 8.5fr X 20 Quadro Lumen CVC Set with Nitinol G due to discoveared leakage from the cateter.

The manufacturer has advised users to stop using the affected lots of the medical device 8.5fr X 20 cm Quadro Lumen CVC Set with Nitinol G HH-E8516 and HH-E8521.

Here you may view the safety information.

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