Perfusion Tubing System (2021-04-13)
- Starting date:
- April 13, 2021
- Posting date:
- April 29, 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-75489
Last updated:
2021-04-29
Affected Products
- REVOLUTION CENTRIFUGAL PUMP PERFUSION TUBING PACK PHISIO OR NON-PHISIO COATED
- CSC14 CARDIOPLEGIA PERFUSION TUBING PACK PHISIO COATED
- PERFUSION TUBING SYSTEMS WITH OR W/O PHISIO COATING
- DIDECO PERFUSION TUBING SYSTEMS W/WO PHISIO COATING
Reason
Livanova has been informed that one of its sterilization supplier, was involved in recurrent non conformities in the sterilization process documentation so that its certificate was suspended. Although initial investigation performed by LivaNova on the raw data suggested that LivaNova devices were sterilized in compliance with the validated sterilization process, based on the most recent information received, LivaNova cannot exclude a deviation in the validated processes and has initiated the removal of all the non-expired affected product from the field.
Affected products
A. REVOLUTION CENTRIFUGAL PUMP PERFUSION TUBING PACK PHISIO OR NON-PHISIO COATED
Lot or serial number
1907290175
Model or catalog number
86448
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY
B. CSC14 CARDIOPLEGIA PERFUSION TUBING PACK PHISIO COATED
Lot or serial number
1907290178
Model or catalog number
C23648
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY
C. PERFUSION TUBING SYSTEMS WITH OR W/O PHISIO COATING
Lot or serial number
1907290100
1907290110
1907290111
Model or catalog number
AB0093
AB1189
AB1845
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY
D. DIDECO PERFUSION TUBING SYSTEMS W/WO PHISIO COATING
Lot or serial number
1907290178
Model or catalog number
C23246
Companies
- Manufacturer
-
SORIN GROUP ITALIA S.R.L
VIA STATALE 12 NORD, 86, P.O. BOX 87,
MIRANDOLA, MODENA
41037
ITALY