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CUSTOM HEART LUNG PACKS (2016-01-29)
- Starting date:
- January 29, 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-57208
Affected Products
CUSTOM HEART LUNG PACKS
Reason
Sorin Group USA received a safety alert from Terumo CVS for their CDI H/S Cuvette which is included in custom heart lung packs manufactured by Sorin Group USA. This safety alert calls attention to a situation that may arise with the CDI H/S Cuvette and recommends how to respond should the CDI Blood Parameter Monitoring System 500 display the error message "H/S disconnect at cuvette." this may occur when the CDI H/S Cuvette does not make a proper connection to the CDI H/S probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Affected products
CUSTOM HEART LUNG PACKS
Lot or serial number
1517400079
1521000084
1522400091
1526600054
Model or catalog number
627139306
Companies
- Manufacturer
-
Sorin Group USA Inc.
14401 W. 65TH WAY
ARVADA
80004
Colorado
UNITED STATES