Pressure Monitoring Kit (Sterile) and Vamp Venous Arterial Blood Management Protection System (2019-11-13)
- Starting date:
- November 13, 2019
- Posting date:
- January 6, 2020
- 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-71985
Last updated: 2020-01-07
Affected Products
A. Pressure Monitoring Kit (Sterile)
B. Vamp Venous Arterial Blood Management Protection System
Reason
This non-conformance is due to the inability to flush a disposable pressure transducer system upon the initiation of priming. If this inability to flush occurs, the clinician can obtain another transducer kit with minimal delay in set-up time. This issue occurs during setup and before use.
Affected products
A. Pressure Monitoring Kit (Sterile)
Lot or serial number
61417781
Model or catalog number
PX3X3
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES
B. Vamp Venous Arterial Blood Management Protection System
Lot or serial number
61386324
61498566
61566872
61576997
61785639
Model or catalog number
PXVP23X3
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES