PEDIASAT OXIMETRY CATHETER SET (2021-07-13)

Starting date:

July 13, 2021

Posting date:

July 22, 2021

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-76075

Last updated:
2021-07-22

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  Reason
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  Affected products

Affected Products 

PEDIASAT OXIMETRY CATHETER SET

Reason

Edwards has received three (3) customer complaints reporting leaks during use. One complaint noted that after administering medication, the physician flushed a different lumen than the one where the medication was administered, and the patient’s vital signs responded to the medication. The other two complaints noted external leakage at the transition from the green hub (backform) to the tube. Edwards has confirmed a manufacturing defect leading to possible interlumen leakage.

Affected products