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Pressure Monitoring Sets (2015-08-18)
- Starting date:
- August 18, 2015
- Posting date:
- October 5, 2015
- 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-55202
Affected Products
- Pressure Monitoring Set
- Pressure Monitoring Kit with VAMP
- Pressure Monitoring Set
Reason
Through post market surveillance, flow restriction was detected from all arterial, CVP and PA lines during priming and flushing. Flow restriction was found inside IV trifurcated adaptor. The IV tubing lumen was blocked by the adaptor and restricted flow paths to extension tubes and pressure lines.
Affected products
A. Pressure Monitoring Set
Lot or serial number
- 987950
- 0020223
- 0036750
Model or catalog number
- 2X3
- 43422A
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES
B. Pressure Monitoring Kit with VAMP
Lot or serial number
- 60025874
Model or catalog number
- PXVMP3X32
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES
C. Pressure Monitoring Set
Lot or serial number
- 994227
- 0025936
Model or catalog number
- PX3X3272
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES