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:

Affected Products 

  1. SECONDARY SET
  2. COMPONENTS AND EXTENSION SETS
  3. ALARIS SMARTSITE NEEDLE-FREE MULTI-WAY CONNECTING SET
  4. 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

  1. 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