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:

Affected Products 

  1. REVOLUTION CENTRIFUGAL PUMP PERFUSION TUBING PACK PHISIO OR NON-PHISIO COATED
  2. CSC14 CARDIOPLEGIA PERFUSION TUBING PACK PHISIO COATED
  3. PERFUSION TUBING SYSTEMS WITH OR W/O PHISIO COATING
  4. 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