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4 Fr. Single lumen powerpicc catheters
Official notice
28 Aug 2025
Last checked
28 Aug 2025
An official Health Canada notice concerns 4 Fr. Single lumen powerpicc catheters. 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 Published 2025-08-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77138
Official notice
2025-08-28
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Bard Access, 4 Fr Single Lumen Powerpicc Catheters.
Source & status
Source & status
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Classification
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Recall details
Recall details
Recall number
Classification
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Documents, notices & source
See the official notice and source documents for full details.
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