Maquet Cardiopulmonary GmbH, 946519, ROTAFLOW Centrifugal Pump and HLS Sets Emergency Priming Line - Let op 2 FSNs

FSN 1: Maquet Cardiopulmonary GmbH (MCP)/Getinge is notifying you about a recall for the ROTAFLOW Centrifugal Pump (RF-32) due to a potentially compromised sterile barrier. During retrospective internal testing, MCP/Getinge discovered narrow channels in the seal of the sterile bags used to package the RF-32. MCP/Getinge receives this sterile bag from a supplier that performs tests to verify sterility. Incomplete sealing can potentially lead to a breach of the sterile barrier.

FSN 2: Maquet Cardiopulmonary GmbH (MCP)/Getinge is notifying you about an issue related to the HLS Sets potentially having a compromised sterile barrier of the Emergency Priming Line.During retrospective internal testing of HLS Set packaging, MCP/Getinge discovered narrow channels in the seal of the sterile bags used to package the Emergency Priming Line (Figure 1 Item 14). MCP/Getinge receives this sterile bag from a supplier that performs tests to verify sterility. Incomplete sealing can potentially lead to a breach of the sterile barrier.