Artiset Blood Tubing Set For Haemodialysis HD SN HC, HD DNL HC & Ultra HDF Post Line (2020-04-23)
- Starting date:
- April 23, 2020
- Posting date:
- May 15, 2020
- 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-73089
Last updated: 2020-05-15
Affected Products
- Artiset Blood Tubing Set For Haemodialysis HD SN HC
- Artiset Blood Tubing Set For Haemodialysis- HD DNL HC
- Ultra HDF Post Line
Reason
Baxter Corporation has received customer complaints of various disconnection events with hemodialysis blood tubing sets. The issue has been isolated to a subset of lots, based on production dates.
Affected products
A. Artiset Blood Tubing Set For Haemodialysis HD SN HC
Lot or serial number
- 1000221056
- 1000225450
- 1000228187
Model or catalog number
- 114533
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY
B. Artiset Blood Tubing Set For Haemodialysis- HD DNL HC
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- 955075
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY
C. Ultra HDF Post Line
Lot or serial number
- 1000230893
- 1000232240
Model or catalog number
- 955037
Companies
- Manufacturer
-
Gambro Dasco S.P.A.
Via Modenese 66
Medolla
41036
ITALY