Sapphire Epidural Set Yellow-Striped Microbore (2018-11-04)

Starting date:

November 4, 2018

Posting date:

November 28, 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-68438

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  Reason
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  Affected products

Affected products

Sapphire Epidural Set Yellow-Striped Microbore

Reason

ICU Medical has identified an issue with the yellow striped sapphire epidural set. It was identified that the inclusion of both a 0.2 micron filter and a Pressure Activated Valve (PAV) with the filter in a proximal location can increase the probability of distal occlusions alarms. This configuration is limited to this sapphire epidural set.

Affected products