Vacuum Unit for CATSmart (2019-02-18)
- Starting date:
- February 18, 2019
- Posting date:
- March 1, 2019
- 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-69198
Affected Products
Vacuum Unit for CATSmart
Reason
Vacuum Unit unexpectedly stops functioning which prevents suction of shed blood from wound/operation area to a reservoir for washing by the CATSmart Autotransfusion System. After the failure message appears, the vacuum pump stops working but the washing procedure continues to function. Defectiveness was discovered from complaints in the field.
Affected products
Vacuum Unit for CATSmart
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9005851
Companies
- Manufacturer
-
Fresenius Kabi AG
Else-Kröner-Straße 1
Bad Homburg vor der Höhe
61352
GERMANY