4 Fr. Single Lumen PowerPICC Catheters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
PowerPICC Catheter Standard Guidewire Basic Kit |
REGZ1397 |
3174118 |
PowerPICC Catheter, Full Tray (With Sherlock 3cg Tps Stylet) |
REHS1080 |
2174108 |
PowerPICC Catheter Standard Guidewire IR Basic Kit |
More than 10 numbers, contact manufacturer. |
3174135 |
PowerPICC Solo2 Catheter, Full Tray (With Sherlock 3cg Tps Stylet) |
REHR1437 |
2194108 |
PowerPICC Solo Catheter, Sl, Nitinol Guidewire |
REHR0025 |
3194335 |
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.
Recall start date: March 11, 2025
Additional information
Details
| Bard Access Systems, Inc. |
| 605 North 5600 West, Salt Lake City, Utah, United States, 84116 |
Get notified
Receive notifications for new and updated recalls and alerts by category.