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VAXCELL PICC with PASV Valve Technology and XCELA Power Injectable PICC (2016-03-14)
- Starting date:
- March 14, 2016
- Posting date:
- April 15, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57962
Affected Products
A. VAXCEL PICC with PASV Catheter Kit
B. VAXCEL PICC with PASV IR-145 Kit and MST-60 Kit
C. XCELA PICC with PASV Technology MST-70 Kit
D. Bioflo PICC with Endexo and PASV Valve Technology Catheter Kit
E. BioFlo PICC with Endexo and PASV Valve Technology IR-145 Kit
F. XCELA Hybrid PICC with PASV Technology IR-145 Kit and MST-70 Kit
Reason
Navilyst Medical is recalling PICC catheters that contain valve(s) manufactured prior to July 15, 2014. Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. Use of the PICC catheters that are subject to this recall may result in an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the PICC catheter.
Affected products
A. VAXCEL PICC with PASV Catheter Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M001454550
M001454700
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
B. VAXCEL PICC with PASV IR-145 Kit and MST-60 Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M001454580
M001454590
M001454640
M001454730
M001454740
M001454790
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
C. XCELA PICC with PASV Technology MST-70 Kit
Lot or serial number
lot # 4783738
Model or catalog number
H965457420
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
D. Bioflo PICC with Endexo and PASV Valve Technology Catheter Kit
Lot or serial number
lot # 4814218
lot # 4835795
Model or catalog number
H965458410
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
E. BioFlo PICC with Endexo and PASV Valve Technology IR-145 Kit
Lot or serial number
lot # 4753201
lot # 4776149
lot # 4797578
lot # 4819459
lot # 4830558
Model or catalog number
H965458840
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
F. XCELA Hybrid PICC with PASV Technology IR-145 Kit and MST-70 Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
H965952420
H965952430
H965952460
H965952470
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES