GP & VP Infusion sets, Infusion Pumps, Secondary Sets, Components & Extension Sets (2021-03-11)
- Starting date:
- March 11, 2021
- Posting date:
- March 23, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75187
Last updated:
2021-03-23
Affected Products
- SECONDARY SET
- COMPONENTS AND EXTENSION SETS
- ALARIS SMARTSITE NEEDLE-FREE MULTI-WAY CONNECTING SET
- ALARIS INFUSION SET. VENTED
Reason
BD recently discovered that Steril Milano, a third-party sterilization facility under contract to BD in Italy, had intentionally falsified their routine process records and are suspected to have falsified the validation documentation related to the sterilization of BD products (primarily IV-related products).
Affected products
-
SECONDARY SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
72951NE
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
B. COMPONENTS AND EXTENSION SETS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
G30402M
G40020B
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
C. ALARIS SMARTSITE NEEDLE-FREE MULTI-WAY CONNECTING SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2305E
2306E
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND
D. ALARIS INFUSION SET. VENTED
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
388000
388002
Companies
- Manufacturer
-
BD Switzerland SARL
Route de Crassier 17, Business Park Terre Bonne
Eysins
1262
SWITZERLAND