Public recall detail

4 Fr. Single Lumen PowerPICC Catheters

2025-03-19

medium
Recall Safety notice
Quick summary

Quick summary: 4 Fr. Single Lumen PowerPICC Catheters. Date: 2025-03-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 4 Fr. Single Lumen PowerPICC Catheters. Date: 2025-03-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBard Access Systems, Inc.
Product4 Fr. Single Lumen PowerPICC Catheters
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77138

Affected products

ProductPowerPICC Catheter, Full Tray (With Sherlock 3cg Tps Stylet)
LotMore than 10 numbers, contact manufacturer.
Model2174108
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Catheter, Full Tray (With Sherlock 3cg Tps Stylet)
ProductPowerPICC Solo2 Catheter, Full Tray (With Sherlock 3cg Tps Stylet)
LotMore than 10 numbers, contact manufacturer.
Model2194108
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Solo2 Catheter, Full Tray (With Sherlock 3cg Tps Stylet)
ProductPowerPICC Solo Catheter, Sl, Nitinol Guidewire
LotMore than 10 numbers, contact manufacturer.
Model3194335
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Solo Catheter, Sl, Nitinol Guidewire
ProductPowerPICC Solo Catheter, Sl, Nitinol Guidewire
LotMore than 10 numbers, contact manufacturer.
Model3194355
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Solo Catheter, Sl, Nitinol Guidewire
ProductPowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer
LotREJQ0411
Model9194118
Serial numberREJQ0411
DescriptionPowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer
ProductPowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer
LotREHV0263
Model9194118
Serial numberREHV0263
DescriptionPowerPICC Solo, Basic Tray With Sherlock* Stylet And Microintroducer
ProductPowerPICC Catheter Sherlock Stylet And Microintroducer
LotREHY2815
Model1174118
Serial numberREHY2815
DescriptionPowerPICC Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Catheter Sherlock Stylet And Microintroducer
LotREJS4488
Model1174118
Serial numberREJS4488
DescriptionPowerPICC Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo Catheter, Sl, Ss Guidewire
LotMore than 10 numbers, contact manufacturer.
Model3194155
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Solo Catheter, Sl, Ss Guidewire
ProductPowerPICC Solo2 Catheter, Full Tray
LotREHY1261
Model6194108
Serial numberREHY1261
DescriptionPowerPICC Solo2 Catheter, Full Tray
ProductPowerPICC Solo2 Catheter, Full Tray
LotREHV1380
Model6194108
Serial numberREHV1380
DescriptionPowerPICC Solo2 Catheter, Full Tray
ProductPowerPICC Solo2 Catheter, Full Tray
LotREJR2094
Model6194108
Serial numberREJR2094
DescriptionPowerPICC Solo2 Catheter, Full Tray
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREGZ1397
Model3174118
Serial numberREGZ1397
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREHQ1835
Model3174118
Serial numberREHQ1835
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREHP1760
Model3174118
Serial numberREHP1760
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREHP2603
Model3174118
Serial numberREHP2603
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREJT1310
Model3174118
Serial numberREJT1310
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREJN1059
Model3174118
Serial numberREJN1059
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire Basic Kit
LotREGT2997
Model3174118
Serial numberREGT2997
DescriptionPowerPICC Catheter Standard Guidewire Basic Kit
ProductPowerPICC Catheter Standard Guidewire IR Basic Kit
LotMore than 10 numbers, contact manufacturer.
Model3174135
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Catheter Standard Guidewire IR Basic Kit
ProductPowerPICC Catheter Standard Guidewire IR Basic Kit
LotMore than 10 numbers, contact manufacturer.
Model3174335
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Catheter Standard Guidewire IR Basic Kit
ProductPowerPICC Catheter Standard Guidewire IR Basic Kit
LotMore than 10 numbers, contact manufacturer.
Model3174155
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Catheter Standard Guidewire IR Basic Kit
ProductPowerPICC Catheter Standard Guidewire IR Basic Kit
LotMore than 10 numbers, contact manufacturer.
Model3174355
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Catheter Standard Guidewire IR Basic Kit
ProductPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
LotREJP0843
Model3194118
Serial numberREJP0843
DescriptionPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
ProductPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
LotREJS0206
Model3194118
Serial numberREJS0206
DescriptionPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
ProductPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
LotREHY1654
Model3194118
Serial numberREHY1654
DescriptionPowerPICC Solo Catheter, Sl, Basic Tray W/Microintroducer/Flexura Guidewire
ProductPowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer
LotREHQ3091
Model9174118
Serial numberREHQ3091
DescriptionPowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer
ProductPowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer
LotREHY2811
Model9174118
Serial numberREHY2811
DescriptionPowerPICC, Basic Tray With Sherlock* Stylet And Microintroducer
ProductPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
LotREJR2055
Model1194118
Serial numberREJR2055
DescriptionPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
LotREJP4189
Model1194118
Serial numberREJP4189
DescriptionPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
LotREJS4487
Model1194118
Serial numberREJS4487
DescriptionPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
LotREJN3013
Model1194118
Serial numberREJN3013
DescriptionPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
LotREJS0031
Model1194118
Serial numberREJS0031
DescriptionPowerPICC Solo2 Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Catheter Sherlock Stylet And Microintroducer
LotREJQ2243
Model1174118
Serial numberREJQ2243
DescriptionPowerPICC Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Catheter Sherlock Stylet And Microintroducer
LotREJN1443
Model1174118
Serial numberREJN1443
DescriptionPowerPICC Catheter Sherlock Stylet And Microintroducer
ProductPowerPICC Solo Catheter, Sl, Ss Guidewire
LotMore than 10 numbers, contact manufacturer.
Model3194135
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPowerPICC Solo Catheter, Sl, Ss Guidewire

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Cardiovascular
CompaniesBard Access Systems, Inc. 605 North 5600 West, Salt Lake City, Utah, United States, 84116
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77138
Background{}
CompaniesBard Access Systems, Inc. 605 North 5600 West, Salt Lake City, Utah, United States, 84116
AudiencesHealthcare Industry
Source updated2025-08-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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