The Heart Lung Machine (HLM) Tubing Set is part of an extracorporeal system and is used exclusively in combination with other devices of that system, e.g. blood pumps, oxygenators etc. The HLM Tubing Sets are designed to be used for circulation of blood and other liquids between the patient and the extracorporeal system. This recall is initated due to an identified issue with the cap on a stopcock, which can restrict airflow into the downstream port. This restriction of flow into the port creates an increased challenge to the sterilization process for the stopcock included in the kit.
All concerned customers have received communication. Customers are requested to return any remaining HLM Tubing Sets for replacement or full credit.
This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities.
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