Stockert Heater Cooler System 3T (2018-10-28)

Starting date:

October 28, 2018

Posting date:

November 15, 2018

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-68236

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  Reason
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  Affected products

Affected products

Stockert Heater Cooler System 3T

Reason

LivaNova is providing updated instructions to monitor the concentration of hydrogen peroxide in the water circuit of the 1T and 3T Heater-Cooler devices, to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm. This regimen enhances the water maintenance regimen outlined in Section 6.4 of the operating instructions.

Affected products