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Health product recall

Aortic Arch Cannulae (2017-06-23)

Starting date:
June 23, 2017
Posting date:
June 30, 2017
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-63792

Affected Products

  1. Aortic Arch Cannulae, NA-001TG
  2. Aortic Arch Cannulae, RA-1137
  3. Aortic Arch Cannulae, NA-1337

Reason

During inspection of product in its inventory, Sorin has identified that plastic flash may be present on the tip of the aortic arch cannulae. There is a risk that flash can become detached during cardiac surgery and be released into the patient's blood circulation, resulting in the possibility of embolism. To mitigate this hazard, Sorin is removing these affected aortic arch cannulae from the marketplace and replacing them with new aortic cannulae which have been verified not to contain flash.

Affected products

A. Aortic Arch Cannulae, NA-001TG

Lot or serial number
  • 1519500072
  • 1528600113
  • 1611700043
  • 1623600028
  • 1627100070
  • 1629800189
  • 1634000158
  • 1701600204
Model or catalog number

NA-001TG

Companies
Manufacturer
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES

B. Aortic Arch Cannulae, RA-1137

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

RA-1137

Companies
Manufacturer
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES

C. Aortic Arch Cannulae, NA-1337

Lot or serial number

1528600115
1530000132
1607500029
1608800130
1611700045
1617900116
1620000013
1700300233

Model or catalog number

NA-1337

Companies
Manufacturer
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES

Date modified: