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:

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

PEDIASAT OXIMETRY CATHETER SET

Lot or serial number
  • 62728569
  • 62889136
  • 62903838
Model or catalog number
  • XT3515SP
Companies
Manufacturer
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES