Smiths Medical issued an urgent field safety notice to warn of corrective action for its LogiCal 5 ml closed blood sampling system sets and HemoDraw Plus closed blood sampling sets with the LogiCal pressure monitoring system.
The company said in the notice out of Germany that it became aware that customers using the LogiCal and HemoDraw sampling sets may experience pressure shifts and incorrect pressure readings during patient monitoring.
If a pressure measurement is inaccurate, it could lead to an inappropriate administration of therapy. If the sensor is presenting incorrect pressure readings, other hemodynamic monitoring systems may be used, which could lead to a delay in therapy. Users could also find it difficult to determine if the device is giving incorrect pressure measurements. According to the safety notice, Smiths Medical has not received any reports of death or serious injury related to the issue.
Users are urged to locate and quarantine the affected products, while also determining the amount of unused affected product in possession. Smiths Medical said all affected products must be returned to Stericycle for processing and not returned directly to the company itself.
According to the safety notice, 19 different models of the sampling sets were affected by the issue.
