Asena GH and Alaris Syringe Pumps (2018-06-25)
- Starting date:
- June 25, 2018
- Posting date:
- July 5, 2018
- 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-67188
Affected products
A. Asena GH + RS232
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 Pediatric 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 + RS232
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
80023FR01
80023GB01
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
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
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
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
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
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
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
E. Alaris CC Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
80033UND1
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
F. Alaris Tiva Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
80043UN01
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
G. Alaris GH Syringe Pump (Rebranding)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
80023UN01
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND