Health product recall

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