Health product recall

CATSmart (2019-04-11)

Starting date:
April 11, 2019
Posting date:
April 18, 2019
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-69628

Last updated: 2019-04-18

Affected Products

CATSmart

Reason

Worn out or leaking centrifuge tubes due to a multifaceted set of events involving the CATSmart systems (device, software and disposable) which may result in the centrifuge tubing line making contact with the washing chamber thereby causing excessive wear on the centrifuge tubing or in extreme cases a puncture of the tubing. 1) The centrifuge tubing line being within specification but not at its nominal length and/or 2) combined with priming acceleration parameters of the CATSmart device.

Affected products

CATSmart

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

9005901

Companies
Manufacturer

Fresenius Kabi AG

Else-Kröner-Straße 1

Bad Homburg vor der Höhe

61352

GERMANY