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