UNICEL DXC SYSTEMS (2016-06-27)

Starting date:

June 27, 2016

Posting date:

November 15, 2016

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-60994

• Reason
• Affected products

Affected Products

1. UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS
2. UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS
3. UNICEL DXC 600I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS
4. UNICEL DXC 880I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS
5. UNICEL DXC 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS
6. UNICEL DXC 680I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS
7. UNICEL DXC 860I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS

Reason

Beckman Coulter has identified an incompatibility between No Foam DxC Reagent (REF B64130) and the DxC Hydropneumatic Parts associated with No Foam Delivery. DxC No Foam Reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the Hydropneumatic Subsystems. Over time, this incompatibility may lead to: breaks in no foam cap assembly (PN A84827), cracks in no foam waste collector (PN A60007/A64665), seepage outside no foam tubing (PN A10027, A10028, and A67123). This incompatibility does not affect No Foam's ability to perform its function and there is no impact to patient results. Cracks in the waste collector may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. Cracks in the No Foam Cap and seepage from the No Foam Tubing may lead to exposure to No Foam.

Affected products