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Sorin 3T Heater-Cooler System
- Starting date:
- October 28, 2016
- Posting date:
- November 15, 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-61056
Affected Products
Reason
This field safety notice updates recommendation is to mitigate the potential risk of nontuberculous mycobacterial (NTM) contamination of Sorin Heater Cooler 3T devices and the potential risk of patient NTM infections. This update follows information released in the U.S. on October 13, 2016.
Affected products
Sorin 3T Heater-Cooler System
Lot or serial number
- More than 10 numbers, contact manufacturer
Model or catalog number
- 16-02-81
- 16-02-82
- 16-02-85
Companies
- Manufacturer
-
Sorin Group Deutschland GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY