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Asena GH and Alaris Syringe Pumps (2017-05-04)
- Starting date:
- May 4, 2017
- Posting date:
- June 5, 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-63490
Affected Products
A. Asena GH
B. Alaris PK Syringe Pump (Rebranding)
C. Alaris GH Syringe Pump With Guardrails Safety Software (Rebranding)
D. Alaris CC Syringe Pump With Guardrails Safety Software (Rebranding)
E. Alaris CC Syringe Pump (Rebranding)
F. Alaris Tiva Syringe Pump (Rebranding)
G. Alaris GH Syringe Pump (Rebranding)
Reason
While the pump is infusing, a breakage of the plunger backplate spring may allow movement of the syringe plunger that may result in siphonage. Neonatal and paediatric patients, or those receiving critical drugs at low infusion rates, would be considered to be the most at risk if small volumes of fluids reach the patient due to siphoning.
Affected products
A. Asena GH
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80023FR01
80023GB01
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
B. Alaris PK Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80053UN01
8005PK201
8005TIG01
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
C. Alaris GH Syringe Pump With Guardrails Safety Software (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
8002MED01-G
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
D. Alaris CC Syringe Pump With Guardrails Safety Software (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80033UND1-G
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
E. Alaris Cc Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80033UND1
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
F. Alaris Tiva Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80043UN01
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND
G. Alaris GH Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
80023UN01
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND