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, Full Tray (With Sherlock 3cg Tps Stylet) |
More than 10 numbers, contact manufacturer. |
2174108 |
PowerPICC Solo2 Catheter, Full Tray (With Sherlock 3cg Tps Stylet) |
More than 10 numbers, contact manufacturer. |
2194108 |
PowerPICC Solo Catheter, Sl, Nitinol Guidewire |
More than 10 numbers, contact manufacturer. |
3194335 |
PowerPICC Solo Catheter, Sl, Nitinol Guidewire |
More than 10 numbers, contact manufacturer. |
3194355 |
PowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer |
REJQ0411 |
9194118 |
PowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer |
REHV0263 |
9194118 |
PowerPICC Catheter Sherlock Stylet And Microintroducer |
REHY2815 |
1174118 |
PowerPICC Catheter Sherlock Stylet And Microintroducer |
REJS4488 |
1174118 |
PowerPICC Solo Catheter, Sl, Ss Guidewire |
More than 10 numbers, contact manufacturer. |
3194155 |
PowerPICC Solo2 Catheter, Full Tray |
REHY1261 |
6194108 |
PowerPICC Solo2 Catheter, Full Tray |
REHV1380 |
6194108 |
PowerPICC Solo2 Catheter, Full Tray |
REJR2094 |
6194108 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REGZ1397 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REHQ1835 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REHP1760 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REHP2603 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REJT1310 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REJN1059 |
3174118 |
PowerPICC Catheter Standard Guidewire Basic Kit |
REGT2997 |
3174118 |
PowerPICC Catheter Standard Guidewire IR Basic Kit |
More than 10 numbers, contact manufacturer. |
3174135 |
PowerPICC Catheter Standard Guidewire IR Basic Kit |
More than 10 numbers, contact manufacturer. |
3174335 |
PowerPICC Catheter Standard Guidewire IR Basic Kit |
More than 10 numbers, contact manufacturer. |
3174155 |
PowerPICC Catheter Standard Guidewire IR Basic Kit |
More than 10 numbers, contact manufacturer. |
3174355 |
PowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire |
REJP0843 |
3194118 |
PowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire |
REJS0206 |
3194118 |
PowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire |
REHY1654 |
3194118 |
PowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer |
REHQ3091 |
9174118 |
PowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer |
REHY2811 |
9174118 |
PowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer |
REJR2055 |
1194118 |
PowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer |
REJP4189 |
1194118 |
PowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer |
REJS4487 |
1194118 |
PowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer |
REJN3013 |
1194118 |
PowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer |
REJS0031 |
1194118 |
PowerPICC Catheter Sherlock Stylet And Microintroducer |
REJQ2243 |
1174118 |
PowerPICC Catheter Sherlock Stylet And Microintroducer |
REJN1443 |
1174118 |
PowerPICC Solo Catheter, Sl, Ss Guidewire |
More than 10 numbers, contact manufacturer. |
3194135 |
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
Additional information
Details
| Bard Access Systems, Inc. |
| 605 North 5600 West, Salt Lake City, Utah, United States, 84116 |
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