This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Stockert Heater-Cooler System 3T
- Starting date:
- August 14, 2017
- 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-64316
Reason
This is a follow-up to previous field safety notices issued in June 2015 and October 2016. Livanova has developed a solution to mitigate the dispersion of aerosols produced by the 3T heater-cooler (3T). The solution is a retrofit upgrade of devices currently in use at facilities and at Livanova to reduce and mitigate potential risk of transmission of nontuberculous mycobacteria (NTM) due to aerosolization.r5, -17T/2A.
Affected products
Stockert Heater-Cooler System 3T
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
16-02-81
16-02-82
16-02-85
Companies
- Manufacturer
-
LIVANOVA DEUTSCHLAND GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY