Rappel de produits de santé

Ultrafilter U9000 (2018-02-27)

Starting date:
February 27, 2018
Posting date:
March 19, 2018
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-66190

Affected products

Ultrafilter U9000

Reason

Baxter Corporation is issuing an urgent medical device correction for the Ultrafilter U9000 lot numbers listed below due to leaks during regular clinical use in conjunction with Artis, AK 98, AND AK 96 dialysis machines. The leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product.  A leaking Ultrafilter U9000 could lead to excessive fluid removal during dialysis and subsequently, hypovolemia.

Affected products

Ultrafilter U9000

Lot or serial number

6-1907-H-01 and Higher
More than 10 numbers, contact manufacturer.

Model or catalog number

U9000

Companies
Manufacturer

Gambro Dialysatoren GmbH

Holger-Crafoord-Strasse 26

Hechingen

72379

GERMANY