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Health product recall

AORTIC ARCH CANNULAE (2016-07-13)

Starting date:
July 13, 2016
Posting date:
August 16, 2016
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-59512

Affected products

A. AORTIC ARCH CANNULAE

Reason

Sorin Group USA has become aware of some aortic arch cannulae (part numbers NA-55X7 and NA-55X8, specific lot range) distributed in the market where the angle of the distal end may be less than specified. The cannulae consist of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. The defective cannulae are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

Affected products

A. AORTIC ARCH CANNULAE

Lot or serial number
  • 1520100050
  • 1529300028
  • 1602600042
Model or catalog number
  • NA-5536
  • NA-5537
  • NA-5538
Companies
Manufacturer
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES