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Various Inline Valve Catheter and its Accessories (2014-07-17)
- Starting date:
- July 17, 2014
- Posting date:
- July 25, 2014
- 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-40711
Recalled Products
A) Inline Valve Only
B) Inline Valve, Catheter, Accessories
C) Inline Valve, Unitized Catheter, Access.
D) Inline Valve, Unit. Bactiseal Cath, Acc.
E) Inline Valve with Siphonguard
F) Inline Valve, Siphonguard, Cath.,Acc.
G) Inline Valve, Siphonguard, Unit. Cath, Acc.
H) Inline Valve, Siphonguard, Unit. Bact. Cath.
Reason
As stated in the Codman programmable valve IFU, the virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm H20. Recent In-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm H20. This may result in a delay in treatment for shunt-related complications.
Affected products
A) Inline Valve Only
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
82-8800
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
B) Inline Valve, Catheter, Accessories
Lot or serial number
All lots
Model or catalog number
82-8801
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
C) Inline Valve, Unitized Catheter, Access.
Lot or serial number
All lots
Model or catalog number
82-8802
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
D) Inline Valve, Unit. Bactiseal Cath, Acc.
Lot or serial number
All lots
Model or catalog number
82-8803
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
E) Inline Valve with Siphonguard
Lot or serial number
CNLCW4
CNMDM3
CNNDH3
CNPB1V
CPBB3H
CPBCR0
Model or catalog number
82-8804
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
F) Inline Valve, Siphonguard, Cath.,Acc.
Lot or serial number
All lots
Model or catalog number
82-8805
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
G) Inline Valve, Siphonguard, Unit. Cath, Acc.
Lot or serial number
All lots
Model or catalog number
82-8806
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
H) Inline Valve, Siphonguard, Unit. Bact. Cath.
Lot or serial number
All lots
Model or catalog number
82-8807
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND