INFUSION SET - BURETTE SET YS MC (2021-08-06)
- Starting date:
- August 6, 2021
- Posting date:
- August 19, 2021
- 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-76259
Last updated:
2021-08-19
Affected Products
- INFUSION SET - BURETTE SET YS MC
- INFUSION SET - V/NV MC SMS DP
- INFUSION SET - V/NV MC SS DP DEHP
- INFUSION SET - V/NV MC MF SMS
- SMARTSITE SYRINGE SET
- SMARTSITE COMPONENTS AND EXTENSION
- SMARTSITE COMPONENTS AND EXTENSION
Reason
Recall is being initiated as based on customer feedback, BD has identified potential issues with the valve of the Needle-free Connector for a number of impacted products codes/lots resulting in difficulty to flush, flow issues, and partial or total occlusions on the Extension Sets with SmartSite⢠and Standalone SmartSite⢠connectors.
Affected products
A. INFUSION SET - BURETTE SET YS MC
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2447-0007
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
B. INFUSION SET - V/NV MC SMS DP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2440-0600
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
C. INFUSION SET - V/NV MC SS DP DEHP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2441-0007
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
D. INFUSION SET - V/NV MC MF SMS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10015012
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
E. SMARTSITE SYRINGE SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10798703
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
F. SMARTSITE COMPONENTS AND EXTENSION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2000E
2000EI
20019E
20035E
20037E
20038E
20039E
20059E
20061E
20159E
2300E-0500
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
G. SMARTSITE COMPONENTS AND EXTENSION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10013902
2000E
2000EA
2000EI
20019E
20035E
20037E
20038E
20039E
2309E
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND