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DUAL STAGE VENOUS RETURN CANNULA (2016-01-25)
- Starting date:
- January 25, 2016
- Posting date:
- February 22, 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-57204
Affected Products
DUAL STAGE VENOUS RETURN CANNULA
Reason
Sorin Group USA became aware that the instructions for use (IFU) included with the low profile, One Piece Dual Stage Venous Return Cannula was for another part number. The IFU included with the parts was for an Arterial Cannulae (catalogue number RA-XXXX). This issue affects this device model and lot only.
Affected products
DUAL STAGE VENOUS RETURN CANNULA
Lot or serial number
1529300018
Model or catalog number
LRD-61046
Companies
- Manufacturer
-
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES