This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Products Recalled by Navilyst Medical (2014-12-31)
- Starting date:
- December 31, 2014
- Posting date:
- February 16, 2015
- 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-43701
Recalled Products
A) Xcela PICC with PASV Valve Technology Catheter Kit
B) Xcela PICC with PASV Valve Technology MST-70 Kit
C) Xcela PICC with PASV Valve Technology IR-145 Kit
D) Xcela PICC with PASV Valve Technology Catheter Kit
E) Xcela PICC with PASV Valve Technology MST-70 Kit
F) Xcela PICC with PASV Valve Technology IR-145 Kit
G) Xcela PICC with PASV Valve Technology MST-70 Kit
H) BioFlo PICC with Endexo and PASV Valve Technology Catheter Kit
I) BioFlo PICC with Endexo and PASV Valve Technology MST-70 Kit
J) BioFlo PICC with Endexo and PASV Valve Technology IF-145 Kit
K) BioFlo PICC with Endexo and PASV Valve Technology Convenience Kit
Reason
Use of the PICC catheters that are subject to this recall may have an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the PICC catheter. To date, no patient injuries (MDRS) have been reported as a result of this issue.
Affected products
A) Xcela PICC with PASV Valve Technology Catheter Kit
Lot or serial number
4676186
4676912
4680022
4689263
Model or catalog number
H965457110
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
B) Xcela PICC with PASV Valve Technology MST-70 Kit
Lot or serial number
4607732
4613262
4654012
4665152
4669484
4674869
4683551
4693369
4708662
Model or catalog number
H965457170
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
C) Xcela PICC with PASV Valve Technology IR-145 Kit
Lot or serial number
4600278
4607726
4610120
4640043
4643149
4648838
4651735
4656617
4659281
4660079
4668663
4671419
4675595
4681130
4689262
4696364
4701060
4702453
Model or catalog number
H965251240
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
D) Xcela PICC with PASV Valve Technology Catheter Kit
Lot or serial number
4607737
4633783
4645300
4648931
4678724
4692032
Model or catalog number
H965457310
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
E) Xcela PICC with PASV Valve Technology MST-70 Kit
Lot or serial number
4600280
4607560
4607561
4613382
4613383
4613384
4613385
4633774
4648913
4648914
4648915
4658877
4672190
4672191
4683552
4689264
4698930
Model or catalog number
H965457320
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
F) Xcela PICC with PASV Valve Technology IR-145 Kit
Lot or serial number
4600281
4607563
4607564
4607565
4607566
4607726
4613221
4613222
4633551
4633552
4648889
4648890
4656617
4658023
4658024
4659281
4665958
4665959
4669311
4671419
4675595
4675999
4676187
4678077
4681130
4683245
4687350
4689265
4694085
4696364
4696365
4701060
Model or catalog number
H965251260
H965457130
H965457180
H965457330
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
G) Xcela PICC with PASV Valve Technology MST-70 Kit
Lot or serial number
4613405
4633810
4645105
4649017
4673620
4681128
4694503
Model or catalog number
H965457020
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
H) BioFlo PICC with Endexo and PASV Valve Technology Catheter Kit
Lot or serial number
4604767
4607784
4613314
4613315
4613316
4617923
4617924
4617925
4633679
4633710
4633711
4633712
4633713
4633714
4648859
4659282
4659283
4667067
4667068
4674873
4683555
4683556
4687789
4688876
4690565
4690566
4696366
4696368
4696369
4696370
4703539
4706486
Model or catalog number
H965458110
H965458310
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
I) BioFlo PICC with Endexo and PASV Valve Technology MST-70 Kit
Lot or serial number
4607656
4617953
4633674
4638078
4640519
4640520
4644315
4644316
4645106
4645966
4646985
4646986
4648831
4652330
4656621
4657753
4658429
4665147
4669160
4671425
4671966
4677231
4678428
4683557
4685705
4689268
4691808
4692195
4697582
4706588
4708320
Model or catalog number
H965458890
H965458900
H965458910
H965458920
H965458940
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
J) BioFlo PICC with Endexo and PASV Valve Technology IF-145 Kit
Lot or serial number
4607770
4607772
4613339
4642078
4644117
4644313
4646979
4646981
4646982
4646983
4671634
4684837
4689015
4699577
4709595
4721805
Model or catalog number
H965458130
H965458330
H965458810
H965458820
H965458830
H965458840
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES
K) BioFlo PICC with Endexo and PASV Valve Technology Convenience Kit
Lot or serial number
4703781
4707503
Model or catalog number
H96560M7801281
Companies
- Manufacturer
-
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH
01752
Massachusetts
UNITED STATES