Recall Monitor4 Fr. Single Lumen PowerPICC Catheters
· Published by Health Canada · Official notice
Details
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| PowerPICC Catheter Standard Guidewire Basic Kit | REGZ1397 REGT2997 | 3174118 |
| PowerPICC Catheter, Full Tray (With Sherlock 3cg Tps Stylet) | REHS1080 REGY0240 REHR1459 REGX0239 REGV0410 | 2174108 |
| PowerPICC Catheter Standard Guidewire IR Basic Kit | More than 10 numbers, contact manufacturer. | 3174135 3174335 3174155 3174355 |
| PowerPICC Solo2 Catheter, Full Tray (With Sherlock 3cg Tps Stylet) | REHR1437 REHR0118 REHQ3599 | 2194108 |
| PowerPICC Solo Catheter, Sl, Nitinol Guidewire | REHR0025 REHR0007 | 3194335 3194355 |
Issue
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