BD has seen an increase of material fatigue leaks on the 4 Fr. single lumen PowerPICC catheters in specific geographies. BD has conducted a comprehensive investigation, and we have identified that three lots of resin used to extrude the tubing material exceeded our supplier's specification for a material property called Melt Flow Index (MFI). Our investigation has shown that higher MFI could lead to increased material fatigue leaks. All of the extruded catheters meet BD specifications for dimensions and mechanical properties; however, BD is removing all product from the field that was extruded from resin that exceeded the supplier specification. BD has identified two additional contributing factors to the increase in material fatigue leaks we are seeing on 4 Fr. single lumen PowerPICCs in some geographies. These factors are securement system type and catheter insertion and dressing. Based on further investigation, BD is expanding the product removal to include additional lots of products and clarifying its instructions for customers. Recall start date: May 20, 2025
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