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Vital-Port Vascular Access Ports and Systems (2017-11-28)
- Starting date:
- November 28, 2017
- Posting date:
- December 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65458
Affected products
- VITAL-PORT VASCULAR ACCESS PORT
- VITAL-PORT MRI VASCULAR ACCESS SYSTEM PORT
- VITAL-PORT MINI VASCULAR ACCESS
- VITAL-PORT PETITE VASCULAR ACCESS PORT
- VITAL-PORT MRI PETITE VASCULAR ACCESS
- VITAL-PORT PETITE DUAL LUMEN VASCULAR ACCESS
Reason
The non-coring needle included with the sets has the potential to dislodge silicone from the septum of the port component. Hypothetically, this could lead to embolization of a fragment or leakage of medication/injectable fluids into surrounding tissues. Neither of these potential consequences has been reported.
Affected products
A. VITAL-PORT VASCULAR ACCESS PORT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-7110
IP-S6010
IP-S6110
IP-S7010
IP-S7110
IP-S9010
IP-S9110
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
B. VITAL-PORT MRI VASCULAR ACCESS SYSTEM PORT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-7112
IP-9112
IP-S6112
IP-S7112
IP-S9012
IP-S9112
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
C. VITAL-PORT MINI VASCULAR ACCESS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-5116
IP-S5116
IP-S5116W
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
D. VITAL-PORT PETITE VASCULAR ACCESS PORT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-6113
IP-S6013
IP-S6113
IP-S6113-MPIS-NT
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
E. VITAL-PORT MRI PETITE VASCULAR ACCESS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-S5118
IP-S6118
IP-S6118-MPIS-NT
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
F. VITAL-PORT PETITE DUAL LUMEN VASCULAR ACCESS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IP-S7029
IP-S7129
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES