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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