SenTec Digital Monitoring System V-Sign Membrane Changer (2019-05-07)

Starting date:

May 7, 2019

Posting date:

June 7, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70121

Last updated: 2019-06-07

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  Reason
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  Affected products

Affected Products

SenTec Digital Monitoring System V-Sign Membrane Changer

Reason

SenTec has initiated a field corrective action to address an issue associated with a manufacturing defect that occurred for certain inserts. Due to a manufacturing issue of the electrolyte cartridge of certain membrane changer inserts, there is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure if a MC with such an insert is used.

Affected products