Health product recall

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