Artiset Blood Tubing Set For Haemodialysis HD SN HC

Starting date:

November 30, 2016

Posting date:

December 9, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61380

• Reason
• Affected products

Reason

Baxter Corporation is issuing a safety alert communication to inform customers of the potential for disconnection of the Artiset Bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. Baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. The arterial and venous patient connectors are designed in compliance with the applicable international standards ISO594 and ISO8638, allowing safe connection to vascular accesses. The post-market surveillance reports of disconnection of the Artiset Bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. To address this issue, Baxter is providing additional instructions on how to properly connect the devices.

Affected products